49
STRATAFIX Knotless Tissue Control Devices Product & Procedure Compendium A versatile portfolio to meet your wound closure needs Stratafix The third-party trademarks used herein are trademarks of their respective owners.

STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

  • Upload
    others

  • View
    6

  • Download
    0

Embed Size (px)

Citation preview

Page 1: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

STRATAFIX™ Knotless Tissue Control Devices Product & Procedure CompendiumA versatile portfolio to meet your wound closure needs

Stratafix™

The third-party trademarks used herein are trademarks of their respective owners.

Page 2: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

2

Closure by Tissue Layer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

STRATAFIX™ Knotless Tissue Control Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

Plus Antibacterial Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6

Needle Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8

Needle & Trocar Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Specialties

Bariatric & Upper GI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Cardiovascular . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Colorectal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

HPB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

OB/GYN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29

Orthopedics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Plastics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42

Urology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .45

Table of Contents

STRATAFIX™ Knotless Tissue Control Devices Product & Procedure Compendium

Click any specialty to view recommended product codes

Page 3: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

3

Table of Contents

For optimal surgical results, successful wound closure is essential

MAXIMUM VERSATILITY ENABLED THROUGH A VARIETY OF ANCHOR DESIGNS AND POLYMER TYPES

Tissue TypeHealing Time Period

STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices

STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Devices

STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Devices

STRATAFIX™ Spiral Polypropylene Knotless Tissue Control Devices

Skin (subcuticular) 1-2 weeks ü

Fat (subcutaneous) 1-2 weeks ü ü ü

Fascia 3+ weeks ü

Deep Tissue 4-6 weeks ü ü

Organ Varies ü* ü* ü* ü*

*See Warnings and Precautions section of package insert.

To help achieve their goals for various surgical specialties, surgeons can turn to the STRATAFIX™ Knotless Tissue Control Device portfolio from Ethicon

Page 4: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

4

Table of Contents

STRATAFIX™ Knotless Tissue Control DevicesAn unmatched portfolio to meet your wound-closure needs

More Security• More wound-holding security than interrupted suturing, without knot-related complications1-9

• In preclinical studies, cutting the STRATAFIX Knotless Tissue Control Device did not result in tissue separation2,3,5,6

• Anchors running along the length of the device provide secure fixation with every pass

More Consistency• Compared with traditional sutures, STRATAFIX Knotless Tissue Control Devices help you

easily manage tension and control approximation during closure6,8,10

More Efficiency• Eliminates knot tying

• Anchors lock into place after each pass, eliminating the need to have an assistant follow the suture

• Potentially less time under anesthesia7,8

References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs Various Products. 2015. Ethicon, Inc. 2. Ethicon study AST-2012-0331. Tissue gapping under tension of porcine cadaveric skin incisions closed with Stratafix Spiral in comparison to Monocryl in both interrupted and continuous stitching patterns. Approved on August 24, 2012. Ethicon, Inc. 3. AST-2013-0056 Performance Testing of STRATAFIX Symmetric PDSSize2-0 suture device for Tissue Holding Strength with Multiple Incision Defects to Measure Gapping. Ethicon, Inc. 4. Ethicon study PSE 09-0204, project number 11822. Exploratory histological and biomechanical evaluation of DOLFIN following closure of the ventral abdominal wall in a porcine model at 7±1 days. Approved on July 7, 2010. Ethicon, Inc. 5. Ethicon Performance Evaluation Memo AST-2012-0510. Performance Testing of STRATAFIX Symmetric Size 2-0 suture device for Tissue Holding Strength with an Incision Defect to Measure Gapping. Dated December 3, 2012. Ethicon, Inc. 6. Vakil JJ, O’Reilly MP, Sutter EG, Mears SC, Belkoff SM, Khanuja HS. Knee arthrotomy repair with a continuous barbed suture: a biomechanical study. J Arthroplasty. 2011;26(5):710-713. 7. Eickmann T, Quane E. Total knee arthroplasty closure with barbed sutures. J Knee Surg. 2010;23(3):163-167. 8. Levine BR, Ting N, Della Valle CJ. Use of a barbed suture in the closure of hip and knee arthroplasty wounds. Orthopedics. 2011;34(9):e473-e475. doi: 10.3928/01477447-20110714-35. 9. Einarsson JI, Chavan NR, Suzuki Y, Jonsdottir G, Vellinga TT, Greenberg JA. Use of bidirectional barbed suture in laparoscopic myomectomy: evaluation of perioperative outcomes, safety, and efficacy. J Minim Invasive Gynecol. 2011;18(1):92-95. 10. Moran ME, Marsh C, Perrotti M. Bidirectional-barbed sutured knotless running anastomosis v classic Van Velthoven suturing in a model system. J Endourol. 2007;21(10):1175-1178.

Page 5: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

5

Table of Contents

Symmetric

Fixation tab anchors the device without the need for tying a knot

Intact core and geometrically patterned anchors deliver strength and security with every pass

References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs Various Products. 2015. Ethicon, Inc. 2. Ethicon study AST-2011-0210. Study to evaluate the tissue holding performance at time zero of DOLFIN PDS PLUS barbed suture sizes 1 and 2-0 vs dyed PDS II Plus suture sizes 1 and 2-0 in a continuous stitch pattern—Project DOLFIN 11822, version 1. Approved on July 15, 2011. 3. Ethicon study AST-2011-0341. Performance testing of DOLFIN PDS PLUS size 3-0 suture—tissue holding 10 cm incision. Approved on August 22, 2011. Ethicon, Inc. 4. Ethicon study PSE 09-0204, project number 11822. Exploratory histological and biomechanical evaluation of DOLFIN following closure of the ventral abdominal wall in a porcine model at 7±1 days. Approved on July 7, 2010. Ethicon, Inc. 5. Ethicon study PSE 10-0012, project number 11822. Model development: histological and biomechanical evaluation of 3-0 DOLFIN barbed suture prototypes, 3-0 Quill suture, and 3-0 V-loc suture at 7±1 days following closure of the ventral abdominal wall in a rabbit model. Approved on August 8, 2011. Ethicon, Inc. 6. Performance Testing of STRATAFIX SYMMETRIC PDS PLUS Size 0 & 1 Devices – Initiation Strength in Porcine Tissue. AST-2013-0603. Ethicon, Inc. 7. Ming X, Rothenburger S, Nichols MM. In vivo and in vitro antibacterial efficacy of PDS Plus (polidioxanone with triclosan) suture. Surg Infect (Larchmt). 2008;9(4):451457.

STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesOnly Ethicon offers a knotless tissue control device that is appropriate for closing high-tension areas, such as fascia1-7

Pressed symmetrical anchors maintain

the core of the device

Superior tissue- holding strength

compared to interrupted

technique with Coated

VICRYL® (polyglactin 910)

Suture, continuous

technique with PDS® II

(polydioxanone) Suture,

and V-Loc™ 180 Wound

Closure Device1

STRATAFIX Symmetric

PDS Plus Device offers

Plus Antibacterial Technology to address

a known risk factor

for surgical site

infection (SSI)7*

* The petri dish image is for illustrative purposes only; zone of inhibition testing results can vary.

Page 6: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

6

Table of Contents

STRATAFIX™ Spiral Knotless Tissue Control DevicesA broad range of bidirectional and unidirectional devices offers the smooth glide of a traditional suture and Plus Antibacterial Technology1-7

STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Devices

STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Devices

Spiral anchor configuration provides a secure, 3-dimensional hold 1-7

Anchors retract into the core for a smooth pull through tissue, then re-engage for a secure hold 1-7

References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs Various Products. 2015. Ethicon, Inc. 2. Ethicon study AST-2012-0331. Tissue gapping under tension of porcine cadaveric skin incisions closed with Stratafix Spiral in comparison to Monocryl in both interrupted and continuous stitching patterns. Approved on August 24, 2012. Ethicon, Inc. 3. Vakil JJ, O’Reilly MP, Sutter EG, Mears SC, Belkoff SM, Khanuja HS. Knee arthrotomy repair with a continuous barbed suture: a biomechanical study. J Arthroplasty. 2011;26(5):710-713. 4. Eickmann T, Quane E. Total knee arthroplasty closure with barbed sutures. J Knee Surg. 2010;23(3):163-167. 5. Levine BR, Ting N, Della Valle CJ. Use of a barbed suture in the closure of hip and knee arthroplasty wounds. Orthopedics. 2011;34(9):e473-e475. doi: 10.3928/01477447-20110714-35. 6. Einarsson JI, Chavan NR, Suzuki Y, Jonsdottir G, Vellinga TT, Greenberg JA. Use of bidirectional barbed suture in laparoscopic myomectomy: evaluation of perioperative outcomes, safety, and efficacy. J Minim Invasive Gynecol. 2011;18(1):92-95. 7. Moran ME, Marsh C, Perrotti M. Bidirectional-barbed sutured knotless running anastomosis v classic Van Velthoven suturing in a model system. J Endourol. 2007;21(10):1175-1178.

Unidirectional design,

with Plus Antibacterial

Technology, has adjustable

loop on end*

Anchors formed within

the core of the device

in a spiral pattern

Bidirectional design

allows for management

of tension from

the middle

* The petri dish image is for illustrative purposes only; zone of inhibition testing results can vary.

STRATAFIX Spiral Devices and STRATAFIX Spiral Devices with Plus Antibacterial Technology

Page 7: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

7

Table of Contents

STRATAFIX™ Knotless Tissue Control Devices The only commercially available knotless tissue control devices with antibacterial protection — designed to address a known risk factor associated with surgical site infection (SSI)

References: 1. Rothenburger S, Spangler D, Bhende S, Burkley D. In vitro antimicrobial evaluation of coated Vicryl Plus Antibacterial Suture (coated polyglactin 910 with triclosan) using zone of inhibition assays. Surg Infect (Larchmt). 2002;3 (suppl):S79-S87. 2. Ming X, Rothenburger S, Yang D. In vitro antibacterial efficacy of Monocryl Plus Antibacterial Suture (poligelcaprone 25 with triclosan). Surg Infect (Larchmt). 2007;8(2):201-207. 3. Ming X, Rothenburger S, Nichols MM. In vivo and in vitro antibacterial efficAcy of PDS Plus (polidioxanone with triclosan) suture. Surg Infect (Larchmt). 2008;9(4):451-457. 4. Berríos-Torres SI, Umscheid CA, Bratzler DW, et al. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Surg. doi:10.1001/jamasurg.2017.0904. 5. Global guidelines on the prevention of surgical site infection. World Health Organization website. http://www.who.int/gpsc/ssi-prevention-guidelines/en/. Accessed March 23, 2017. 6. Ban KA, Minei JP, Laronga C, et al. American College of Surgeons and Surgical Infection Society: Surgical Site Infection Guidelines, 2016 Update. J Am Coll Surg. 2016;224:59-74.

*The CDC, WHO, ACS & SIS guidelines on reducing the risk of surgical site infections are general to triclosan-coated sutures and are not specific to any one brand.

Centers for Disease Controland Prevention (CDC)

Guideline for the Prevention ofSurgical Site Infections 2017*

“Consider the use of triclosan-coatedsutures for the prevention of SSI.” 4

World Health Organization (WHO)Global Guidelines for

The Prevention of Surgical Site Infection*

The panel suggests the use oftriclosan coated sutures for the

purpose of reducing the riskof SSI, independent of the

type of surgery.5

Triclosan Coated Sutures are now supported by:

The use of triclosan coated sutureis recommended for wound closure

in clean and clean-contaminatedabdominal cases when available.6

American College of SurgeonsSurgical Infection Society (ACS & SIS)Surgical Site Infection Guidelines, 2016 Update*

Plus Sutures have been shown in vitro to inhibit colonization of the suture for 7 days or more, including bacteria commonly associated with surgical site infection (SSI). 1-3

PROVEN EFFECTIVE AGAINST:

Staphylococcus aureus

Staphylococcus epidermidis

Escherichia coli*

Klebsiella pneumoniae*

Methicillin-resistant Staphylococcus epidermidis (MRSE)Methicillin-resistantStaphylococcus aureus (MRSA) The petri dish image is for illustrative purposes only.

Zone of inhibition testing results can vary. The petri dish image is for illustrative purposes only.

Z f i hibiti t ti lt

*PDS® Plus Antibacterial (polydioxanone) Suture and MONOCRYL® Plus Antibacterial (poliglecaprone 25) Suture only

Page 8: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

8

Table of Contents

1/2 Circle

Ethicon Needle Types

Cutting Edge

PRECISION POINT

Reverse Cutting Conventional Cutting

3/8 Circle 1/2 Circle 3/8 Circle

P-6

P-1

P-3

PS-3

PS-2

PS-1

C-2

C-3

M-2

M-1

J-1

X-8

X-6

X-1

OS-2

LS-1

LS

OS-4

OS-6

OS-8

CP-2

CP-1

CP

CPX

CPXX

FS-3

FS-2

FS-1

FS

FSL

FSLX

LR

KP-3

CPS-3

CR-1

P-2

PS-6

PS-5

PS

PSL

PSLX

PS-4

PS-4c

REVERSE CUTTING

3/8 Circle

Page 9: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

9

Table of Contents

MICRO-POINT® ULTIMA®

Reverse Cutting Spatula

3/8 Circle 1/2 Circle 1/8 Circle 1/4 Circle 3/8 Circle 1/2 Circle

G-6

G-1

G-3

G-7

G-2

CS44-6 CS90-6

CS100-8

CS140-6

CS140-8

CS-B-6

CSM-6

CS160-4

CS160-6

CS175-6

CS160-8

CS175-8

CS-C-6

ULTIMA® SPATULA

Bi-Curve Compound Curve 1/4 Circle 3/8 Circle 1/2 Circle

TG100-8

CTC-6

CTC-6L

VAS100-4

TGW140-4

TG140-6

TG140-8 TG160-4-3M

TG160-4

TG160-6

TG160-8

TG175-8

OPS-5

S-29

S-4

TG4-S TG6-C

S-28 SM-1 S-14

S-24

S-22

S-2

S-12 RD-1

STC-6

SABERLOC®

Conventional Spatula Spatula Center Point Spatula

1/4 Circle 1/2 Circle 1/8 Circle 1/4 Circle 1/2 Circle

Straight Transchamber Bi-Curve Compound Curve

TG6-S

PC-1 PC-12

PRECISION COSMETIC

Conventional Cosmetic Prime®

3/8 Circle 1/2 Circle

PC-3 PC-5

SC-1

KS-1

TS

KS

SKS

CCS-ST

BN

SK-3

SKS-3

STRAIGHT

Page 10: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

10

Table of Contents

CP-C PB-1CCS CCS-1

STERNUM COMPOUND CURVE SKI

1/4 Circle 3/8 Circle

BV30-2

TF-5

MF-1

MF

UR-6

UR-5

UR-4

BVH100-3

TF-6

TF-4

TF-1

RB-4

RB-3

TF

UCL

RB-2

UCLX

RB-1

SH-2

RS

SH-1

SH

MH-1

MH

LH

XLH

XLH-1

XXLH

MO-7

MO-6

MO-5

MO-4

MO-2

CT-3

CT-2

CT-1

CT

CTX

TP-1

BV50-3

BV75-3

BV75-4

BV100-3

BV100-4

BV130-3

BV130-4

BV130-5

BV175-5

BV175-6

BV175-7

BV175-8

BV-1

BV

C-1

BB

BB-1

TE-2

TE

TE-1

5/8 Circle 1/2 Circle

STRAIGHT SKI

ST100-3

ST-4

ST-3

ST-1

ST

SIF-2

Taper Point

Page 11: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

11

Table of Contents

Tapercut®

Trocar

1/2 Circle Ethiguard®

BP-2

BP-1

BP

SHB

CTB-2

CTB-1

CTB

CTXB

TPB-1

Blunt Point

3/8 Circle 1/4 Circle Straight 1/2 Circle

V130-3

V130-4

V130-5

CC

CC-1

V-18

V-4

V-3

V75-3

V100-3

RV-2

CIF-4

V-5

V-6

V-7

V-34

V-37

V-40

V-56

V-26

STP-10

V-47

EN-S

EN-1 EN-5 EN-4TQ

EN-2

TN DT-6 V-38

Endoscopy

Taperpoint Tapercut®

EN-3

Page 12: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

12

Table of Contents

References: 1. Technical Memo CT12-009. December 12, 2012. Ethicon, Inc. 2. Technical Memo CT09-022. January 20, 2010. Ethicon, Inc.

STRATAFIX™ Knotless Tissue Control Devices are paired with superior Ethicon needles1,2

Needles and Trocar Chart

Needle Curvature Length (mm) Trocar Diameter (mm)

5 8 11 12 15

RB-1 1/2 17 No Yes Yes Yes Yes

CT-3 1/2 22 No Yes Yes Yes Yes

SH-1 1/2 22 No Yes Yes Yes Yes

CT-2 1/2 26 No Yes Yes Yes Yes

CP-2 1/2 26 No No Yes Yes Yes

SH 1/2 26 No No Yes Yes Yes

OS-6 1/2 36 No No No Yes Yes

MH 1/2 36 No No No Yes Yes

CT-1 1/2 36 No No No Yes Yes

CTB-1 1/2 36 No No No Yes Yes

MO-4 1/2 36 No No No No Yes

CT 1/2 40 No No No No Yes

OS-8 1/2 40 No No No No Yes

CTX 1/2 48 No No No No No

CTXB 1/2 48 No No No No No

V-7 1/2 26 No Yes Yes Yes Yes

V-34 1/2 36 No No No Yes Yes

V-4 3/8 17 No Yes Yes Yes Yes

PS-2 3/8 19 No Yes Yes Yes Yes

FS-2 3/8 19 No Yes Yes Yes Yes

PS-1 3/8 24 No Yes Yes Yes Yes

FS-1 3/8 24 No Yes Yes Yes Yes

FS 3/8 26 No Yes Yes Yes Yes

V-26 3/8 26 No Yes Yes Yes Yes

PSL 3/8 30 No No Yes Yes Yes

BB 3/8 17 No Yes Yes Yes Yes

ST-4 Straight 19 Yes Yes Yes Yes Yes

EN-S Half-curved 30 Yes Yes Yes Yes Yes

UR-6 5/8 26 No No Yes Yes Yes

Page 13: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

13

Table of Contents

Bariatric & Upper GINISSEN FUNDOPLICATION

Gastric Fundus Plication

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral PDS PlusCT-1, 36 mm, 1/2 CircleTaper Point

612

1530

SXPP1B409SXPP1B410

SXPP1B406SXPP1B450 SXPP1B429

Dyed

Spiral PDOMH, 36 mm, 1/2 CircleTaper Point

3 x 35 x 5

7 x 714 x 14

SXPD2B406SXPD2B407 SXPD2B409

Dyed

Spiral PDOCT-3, 22 mm, 1/2 CircleTaper Point

5 x 5 14 x 14 SXPD2B404 Dyed

Spiral PDOSH, 26 mm, 1/2 CircleTaper Point

4 x 45 x 5

10 x 1014 x 14

SXPD2B413SXPD2B414

Dyed

HIATAL & PARAESOPHAGEAL HERNIA

Crura

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral Polypropylene

SH-1, 22 mm, 1/2 CircleTaper Point

12 30 SXPL1B400 Undyed

Spiral Polypropylene

CT-3, 22 mm, 1/2 CircleTaper Point

5 x 5 14 x 14 SXPL2B401 Undyed

Spiral Polypropylene

CT-1, 36 mm, 1/2 CircleTaper Point

9 x 9 24 x 24 SXPL2B400 Undyed

ROUX-EN-Y GASTRIC BYPASS

Mesenteric Defect at the Jejunojejunostomy (Mesentery)

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral Polypropylene

SH-1, 22 mm, 1/2 CircleTaper Point

12 30 SXPL1B400 Undyed

Page 14: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

14

Table of Contents

GASTRECTOMY

Oversew Staple Line (Stomach)

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral PDOCT-3, 22 mm, 1/2 CircleTaper Point

5 x 5 14 x 14 SXPD2B404 Dyed

Spiral PDOMH, 36 mm, 1/2 CircleTaper Point

5 x 5 14 x 14 SXPD2B409 Dyed

Spiral PDS PlusCT-1, 36 mm, 1/2 CircleTaper Point

18 45 SXPP1B430 Dyed

Omentalpexy

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral PDS PlusSH, 26 mm, 1/2 CircleTaper Point

612

1530

SXPP1B420 SXPP1B415SXPP1B416

Dyed

Page 15: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

15

Table of Contents

CardiovascularCABG

Sternal Closure

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral MONOCRYL Plus

PS-1, 24 mm, 3/8 CircleReverse Cutting

18 45 SXMP1B102 Undyed

Spiral MONOCRYL Plus

PS-2, 19 mm, 3/8 CircleReverse Cutting

18 45 SXMP1B107 Undyed

THORACIC

Thoracotomy Closure

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral MONOCRYL Plus

PS-2, 19 mm, 3/8 CircleReverse Cutting

18 45 SXMP1B107 Undyed

Spiral MONOCRYL Plus

PS-1, 24 mm, 3/8 CircleReverse Cutting

18 45 SXMP1B102 Undyed

VATS Lobectomy – Extraction Site Closure

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral MONOCRYL Plus

PS-2, 19 mm, 3/8 CircleReverse Cutting

1812

4530

SXMP1B118SXMP1B117

SXMP1B107Undyed

EP CATH LAB PACEMAKER

Pacemaker Pocket

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral PDS PlusCT-1, 36 mm, 1/2 CircleTaper Point

6 15 SXPP1B409 Dyed

Spiral PDS PlusCT-2, 26 mm, 1/2 CircleTaper Point

627

1570

SXPP1B413SXPP1B414

Dyed

Spiral PDS PlusSH-1, 22 mm, 1/2 CircleTaper Point

9 22 SXPP1B454 SXPP1B453 Dyed

Spiral MONOCRYL Plus

SH, 26 mm, 1/2 CircleTaper Point

9 23 SXMP1B427 Undyed

Spiral MONOCRYL Plus

PS-2, 19 mm, 3/8 CircleReverse Cutting

12 30 SXMP1B117 Undyed

Page 16: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

16

Table of Contents

ColorectalLOWER ANTERIOR RESECTION

Fascia

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Symmetric PDS Plus

CT-1, 36 mm, 1/2 CircleTaper Point

18 45 SXPP1A401 SXPP1A404 Dyed

Symmetric PDS Plus

CT, 40 mm, 1/2 CircleTaper Point

18 45 SXPP1A406 SXPP1A405 Dyed

Symmetric PDS Plus

CTX, 48 mm, 1/2 CircleTaper Point

18 45 SXPP1A402 SXPP1A400 Dyed

Symmetric PDS Plus

CTXB, 48 mm, 1/2 CircleBlunt Point,ETHIGUARD®Safety Needle

18 45 SXPP1A302 SXPP1A300 Dyed

Symmetric PDS Plus

CTB-1, 36 mm, 1/2 CircleBlunt Point,ETHIGUARDSafety Needle

18 45 SXPP1A301 Dyed

Subcutaneous

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Symmetric PDS Plus

CT-1, 36 mm, 1/2 Circle Taper Point

18 45 SXPP1A403 Dyed

Spiral PDS PlusSH, 26 mm, 1/2 CircleTaper Point

1227

3070

SXPP1B416SXPP1B417

Dyed

Spiral PDS PlusCT-1, 36 mm, 1/2 CircleTaper Point

121827

304570

SXPP1B411SXPP1B412

SXPP1B429Dyed

Spiral PDS PlusPS-4, 16 mm, 1/2 CircleReverse Cutting

18 45 SXPP1B119 Dyed

Spiral PDS PlusX-1, 22 mm, 1/2 CircleReverse Cutting

28 70 SXPP1B120 Dyed

Spiral PDS PlusOS-6, 36 mm, 1/2 CircleReverse Cutting

1827

4570

SXPP1B201SXPP1B203

Dyed

Spiral PDS PlusOS-8, 40 mm, 1/2 CircleReverse Cutting

27 70 SXPP1B204 Dyed

Spiral PDS PlusMO-4, 36 mm, 1/2 CircleTaper Point

27 70 SXPP1B205 Dyed

Page 17: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

17

Table of Contents

Subcutaneous

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral PDS PlusCP-2, 26 mm, 1/2 CircleTaper Point

18 45 SXPP1B403 Dyed

Spiral PDOMH, 36 mm, 1/2 Circle Taper Point

5 x 59 x 9

12 x 1214 x 14

14 x 1424 x 2430 x3036 x 36

SXPD2B407SXPD2B408

SXPD2B412

SXPD2B409SXPD2B410SXPD2B411

Dyed

Spiral MONOCRYL Plus

SH, 26 mm, 1/2 CircleTaper Point

9 23 SXMP1B409 Undyed

Spiral MONOCRYL Plus

CT-1, 36 mm, 1/2 CircleTaper Point

1218

3045

SXMP1B412SXMP1B413

Undyed

Spiral MONOCRYL Plus

CT-2, 26 mm, 1/2 CircleTaper Point

18 45 SXMP1B417 Undyed

Spiral MONOCRYL Plus

PS-1, 24 mm, 3/8 Circle Reverse Cutting

121824

304560

SXMP1B101SXMP1B102SXMP1B103

Undyed

Spiral MONOCRYL Plus

PS-2, 19 mm, 3/8 Circle Reverse Cutting

12182427

30456070

SXMP1B117SXMP1B118

SXMP1B119

SXMP1B106SXMP1B107SXMP1B108

Undyed

Spiral PGA-PCLMH, 36 mm, 1/2 Circle Taper Point

5 x 514 x 14

14 x 1436 x 36

SXMD2B400SXMD2B401

Undyed

Spiral PGA-PCLFS-2, 19 mm, 3/8 Circle Reverse Cutting

5 x 512 x 12

14 x 1430 x 30

SXMD2B407SXMD2B409

SXMD2B406SXMD2B408

Undyed

Spiral PGA-PCLFS, 26 mm, 3/8 Circle Reverse Cutting

5 x 512 x 12

14 x 1430 x 30 SXMD2B413

SXMD2B411SXMD2B412

Undyed

Spiral PGA-PCLFS-1, 24 mm, 3/8 Circle Reverse Cutting

12 x 12 30 x 30 SXMD2B150 SXMD2B410 Undyed

LOWER ANTERIOR RESECTION

Page 18: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

18

Table of Contents

Oversew Staple Line

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral PDOCT-3, 22 mm, 1/2 CircleTaper Point

5 x 5 14 x 14 SXPD2B404 Dyed

Spiral PDOMH, 36 mm, 1/2 CircleTaper Point

3 x 35 x 5

7 x 714 x 14

SXPD2B406SXPD2B407 SXPD2B409

Dyed

Spiral PDOSH, 26 mm, 1/2 CircleTaper Point

4 x 45 x 5

10 x 1014 x 14

SXPD2B413SXPD2B414

Dyed

Spiral PDS PlusCT-1, 36 mm, 1/2 CircleTaper Point

1218

3045

SXPP1B429SXPP1B430

Dyed

SIGMOIDECTOMY/PARTIAL SIGMOIDECTOMY

Fascia

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Symmetric PDS Plus

CT-1, 36 mm, 1/2 CircleTaper Point

18 45 SXPP1A401 SXPP1A404 Dyed

Symmetric PDS Plus

CT, 40 mm, 1/2 CircleTaper Point

18 45 SXPP1A406 SXPP1A405 Dyed

Symmetric PDS Plus

CTX, 48 mm, 1/2 CircleTaper Point

18 45 SXPP1A402 SXPP1A400 Dyed

Symmetric PDS Plus

CTXB, 48 mm, 1/2 CircleBlunt Point,ETHIGUARD®Safety Needle

18 45 SXPP1A302 SXPP1A300 Dyed

Symmetric PDS Plus

CTB-1, 36 mm, 1/2 CircleBlunt Point,ETHIGUARDSafety Needle

18 45 SXPP1A301 Dyed

Subcutaneous

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Symmetric PDS Plus

CT-1, 36 mm, 1/2 Circle Taper Point

18 45 SXPP1A403 Dyed

Spiral PDS PlusSH, 26 mm, 1/2 CircleTaper Point

1227

3070

SXPP1B416SXPP1B417

Dyed

Spiral PDS PlusCT-1, 36 mm, 1/2 CircleTaper Point

121827

304570

SXPP1B411SXPP1B412

SXPP1B429Dyed

LOWER ANTERIOR RESECTION

Page 19: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

19

Table of Contents

Subcutaneous

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral PDS PlusPS-4, 16 mm, 1/2 CircleReverse Cutting

18 45 SXPP1B119 Dyed

Spiral PDS PlusX-1, 22 mm, 1/2 CircleReverse Cutting

28 70 SXPP1B120 Dyed

Spiral PDS PlusOS-6, 36 mm, 1/2 CircleReverse Cutting

1827

4570

SXPP1B201SXPP1B203

Dyed

Spiral PDS PlusOS-8, 40 mm, 1/2 CircleReverse Cutting

27 70 SXPP1B204 Dyed

Spiral PDS PlusMO-4, 36 mm, 1/2 CircleTaper Point

27 70 SXPP1B205 Dyed

Spiral PDS PlusCP-2, 26 mm, 1/2 CircleTaper Point

18 45 SXPP1B403 Dyed

Spiral MONOCRYL Plus

SH, 26 mm, 1/2 CircleTaper Point

9 23 SXMP1B409 Undyed

Spiral MONOCRYL Plus

CT-1, 36 mm, 1/2 CircleTaper Point

1218

3045

SXMP1B412SXMP1B413

Undyed

Spiral MONOCRYL Plus

CT-2, 26 mm, 1/2 CircleTaper Point

18 45 SXMP1B417 Undyed

Spiral MONOCRYL Plus

RB-1, 17 mm, 1/2 CircleTaper Point

612

1530

SXMP1B424SXMP1B425

Undyed

Spiral MONOCRYL Plus

PS-2, 19 mm, 3/8 CircleReverse Cutting

12 30 SXMP1B117 Undyed

Spiral MONOCRYL Plus

PS-1, 24 mm, 3/8 CircleReverse Cutting

121824

304560

SXMP1B101SXMP1B102SXMP1B103

Undyed

Spiral MONOCRYL Plus

PS-2, 19 mm, 3/8 CircleReverse Cutting

12182427

30456070

SXMP1B117SXMP1B118

SXMP1B119

SXMP1B106SXMP1B107SXMP1B108

Undyed

Spiral PDOMH, 36 mm, 1/2 Circle Taper Point

5 x 59 x 9

12 x 1214 x 14

14 x 1424 x 2430 x 3036 x 36

SXPD2B407SXPD2B408

SXPD2B412

SXPD2B409SXPD2B410SXPD2B411

Dyed

SIGMOIDECTOMY/PARTIAL SIGMOIDECTOMY

Page 20: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

20

Table of Contents

Subcutaneous

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral PGA-PCLMH, 36 mm, 1/2 Circle Taper Point

5 x 514 x 14

14 x 1436 x 36

SXMD2B400SXMD2B401

Undyed

Spiral PGA-PCLFS-2, 19 mm, 3/8 Circle Reverse Cutting

5 x 512 x 12

14 x 1430 x 30

SXMD2B407SXMD2B409

SXMD2B406SXMD2B408

Undyed

Spiral PGA-PCLFS, 26 mm, 3/8 Circle Reverse Cutting

5 x 512 x 12

14 x 1430 x 30 SXMD2B413

SXMD2B411SXMD2B412

Undyed

Spiral PGA-PCLFS-1, 24 mm, 3/8 Circle Reverse Cutting

12 x 12 30 x 30 SXMD2B150 SXMD2B410 Undyed

Oversew Staple Line

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral PDS PlusCT-1, 36 mm, 1/2 CircleTaper Point

61218

153045

SXPP1B409SXPP1B410

SXPP1B406SXPP1B450 SXPP1B429

SXPP1B430Dyed

Spiral PDOMH, 36 mm, 1/2 CircleTaper Point

5 x 53 x 3

14 x 147 x 7

SXPD2B407SXPD2B406

SXPD2B409Dyed

Spiral PDOCT-3, 22 mm, 1/2 CircleTaper Point

5 x 5 14 x 14 SXPD2B404 Dyed

Spiral PDOSH, 26 mm, 1/2 CircleTaper Point

4 x 45 x 5

10 x 1014 x 14

SXPD2B413SXPD2B414

Dyed

SIGMOIDECTOMY/PARTIAL SIGMOIDECTOMY

Page 21: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

21

Table of Contents

GeneralLAPAROTOMY CLOSURE

Fascia (Internal/External Oblique, Transversalis, Scarpas)

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Symmetric PDS Plus

CT-1, 36 mm, 1/2 CircleTaper Point

18 45 SXPP1A401 SXPP1A404 Dyed

Symmetric PDS Plus

CT, 40 mm, 1/2 CircleTaper Point

18 45 SXPP1A406 SXPP1A405 Dyed

Symmetric PDS Plus

CTX, 48 mm, 1/2 CircleTaper Point

18 45 SXPP1A402 SXPP1A400 Dyed

Symmetric PDS Plus

CTXB, 48 mm, 1/2 CircleBlunt Point,ETHIGUARD®Safety Needle

18 45 SXPP1A302 SXPP1A300 Dyed

Symmetric PDS Plus

CTB-1, 36 mm, 1/2 CircleBlunt Point,ETHIGUARDSafety Needle

18 45 SXPP1A301 Dyed

Subcutaneous

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Symmetric PDS Plus

CT-1, 36 mm, 1/2 CircleTaper Point

18 45 SXPP1A403 Dyed

Spiral MONOCRYL Plus

SH, 26 mm, 1/2 CircleTaper Point

9 23 SXMP1B409 Undyed

Spiral MONOCRYL Plus

CT-1, 36 mm, 1/2 CircleTaper Point

1218

3045

SXMP1B412SXMP1B413

Undyed

Spiral MONOCRYL Plus

CT-2, 26 mm, 1/2 CircleTaper Point

18 45 SXMP1B417 Undyed

Spiral MONOCRYL Plus

RB-1, 17 mm, 1/2 CircleTaper Point

612

1530

SXMP1B424SXMP1B425

Undyed

Spiral MONOCRYL Plus

PS-1, 24 mm, 3/8 CircleReverse Cutting

121824

304560

SXMP1B101SXMP1B102SXMP1B103

Undyed

Spiral MONOCRYL Plus

PS-2, 19 mm, 3/8 CircleReverse Cutting

12182427

30456070

SXMP1B117SXMP1B118

SXMP1B119

SXMP1B106SXMP1B107SXMP1B108

Undyed

Spiral PDS PlusCT-1, 36 mm, 1/2 CircleTaper Point

1827

4570

SXPP1B411SXPP1B412 SXPP1B431

Dyed

Page 22: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

22

Table of Contents

Subcutaneous

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral PDS PlusOS-6, 36 mm, 1/2 CircleReverse Cutting

1827

4570

SXPP1B201SXPP1B203

Dyed

Spiral PDS PlusOS-8, 40 mm, 1/2 CircleReverse Cutting

27 70 SXPP1B204 Dyed

Spiral PDS PlusMO-4, 36 mm, 1/2 CircleTaper Point

27 70 SXPP1B205 Dyed

Spiral PDS PlusCTX, 48 mm, 1/2 CircleTaper Point

2735

7090

SXPP1B401SXPP1B402

Dyed

Spiral PDS PlusSH, 26 mm, 1/2 CircleTaper Point

1227

3070

SXPP1B416SXPP1B417

Dyed

Spiral PDOMH, 36 mm, 1/2 CircleTaper Point

5 x 59 x 9

12 x 1214 x 14

14 x 1424 x 2430 x 3036 x 36

SXPD2B407SXPD2B408

SXPD2B412

SXPD2B409SXPD2B410SXPD2B411

Dyed

Spiral PGA-PCL MH, 36 mm, 1/2 CircleTaper Point

5 x 514 x 14

14 x 1436 x 36

SXMD2B400SXMD2B401

Undyed

Spiral PGA-PCLFS, 26 mm, 3/8 CircleReverse Cutting

5 x 512 x 12

14 x 1430 x 30 SXMD2B413

SXMD2B411SXMD2B412

Undyed

Spiral PGA-PCLFS-1, 24 mm, 3/8 CircleReverse Cutting

12 x 12 30 x 30 SXMD2B150 SXMD2B410 Undyed

Spiral PGA-PCLFS-2, 19 mm, 3/8 CircleReverse Cutting

5 x 512 x 12

14 x 1430 x 30

SXMD2B407SXMD2B409

SXMD2B406SXMD2B408

Undyed

HIATAL & PARAESOPHAGEAL HERNIA

Crura

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral Polypropylene

SH-1, 22 mm, 1/2 CircleTaper Point

12 30 SXPL1B400 Undyed

Spiral Polypropylene

CT-3, 22 mm, 1/2 CircleTaper Point

5 x 5 14 x 14 SXPL2B401 Undyed

Spiral Polypropylene

CT-1, 36 mm, 1/2 CircleTaper Point

9 x 9 24 x 24 SXPL2B400 Undyed

LAPAROTOMY CLOSURE

Page 23: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

23

Table of Contents

VENTRAL HERNIA

Fascia

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Symmetric PDS Plus

CT-1, 36 mm, 1/2 CircleTaper Point

18 45 SXPP1A401 SXPP1A404 Dyed

Symmetric PDS Plus

CT, 40 mm, 1/2 CircleTaper Point

18 45 SXPP1A406 SXPP1A405 Dyed

Symmetric PDS Plus

CTX, 48 mm, 1/2 CircleTaper Point

18 45 SXPP1A402 SXPP1A400 Dyed

Symmetric PDS Plus

CTXB, 48 mm, 1/2 CircleBlunt Point,ETHIGUARD®Safety Needle

18 45 SXPP1A302 SXPP1A300 Dyed

Symmetric PDS Plus

CTB-1, 36 mm, 1/2 CircleBlunt Point,ETHIGUARDSafety Needle

18 45 SXPP1A301 Dyed

Symmetric PDS Plus

CT, 40 mm, 1/2 CircleTaper Point

18 45 SXPP1A406 SXPP1A405 Dyed

Subcutaneous

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Symmetric PDS Plus

CT-1, 36 mm, 1/2 CircleTaper Point

18 45 SXPP1A403 Dyed

Spiral MONOCRYL Plus

SH, 26 mm, 1/2 CircleTaper Point

9 23 SXMP1B409 Undyed

Spiral MONOCRYL Plus

CT-1, 36 mm, 1/2 CircleTaper Point

1218

3045

SXMP1B412SXMP1B413

Undyed

Spiral MONOCRYL Plus

CT-2, 26 mm, 1/2 CircleTaper Point

18 45 SXMP1B417 Undyed

Spiral MONOCRYL Plus

RB-1, 17 mm, 1/2 CircleTaper Point

612

1530

SXMP1B424SXMP1B425

Undyed

Spiral MONOCRYL Plus

PS-1, 24 mm, 3/8 CircleReverse Cutting

121824

304560

SXMP1B101SXMP1B102SXMP1B103

Undyed

Spiral MONOCRYL Plus

PS-2, 19 mm, 3/8 CircleReverse Cutting

12182427

30456070

SXMP1B117SXMP1B118

SXMP1B119

SXMP1B106SXMP1B107SXMP1B108

Undyed

Page 24: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

24

Table of Contents

Subcutaneous

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral PDS PlusSH, 26 mm, 1/2 CircleTaper Point

1227

3070

SXPP1B416SXPP1B417

Dyed

Spiral PDS PlusCT-1, 36 mm, 1/2 CircleTaper Point

1827

4570

SXPP1B411SXPP1B412 SXPP1B431

Dyed

Spiral PDS PlusPS-4, 16 mm, 1/2 CircleReverse Cutting

18 45 SXPP1B119 Dyed

Spiral PDS PlusX-1, 22 mm, 1/2 CircleReverse Cutting

28 70 SXPP1B120 Dyed

Spiral PDS PlusOS-6, 36 mm, 1/2 CircleReverse Cutting

1827

4570

SXPP1B201SXPP1B203

Dyed

Spiral PDS PlusOS-8, 40 mm, 1/2 CircleReverse Cutting

27 70 SXPP1B204 Dyed

Spiral PDS PlusMO-4, 36 mm, 1/2 CircleTaper Point

27 70 SXPP1B205 Dyed

Spiral PDS PlusCTX, 48 mm, 1/2 CircleTaper Point

2735

7090

SXPP1B401SXPP1B402

Dyed

Spiral PDS PlusCP-2, 26 mm, 1/2 CircleTaper Point

18 45 SXPP1B403 Dyed

Spiral PDOMH, 36 mm, 1/2 CircleTaper Point

5 x 59 x 9

12 x 1214 x 14

14 x 1424 x 2430 x 3036 x 36

SXPD2B407SXPD2B408

SXPD2B412

SXPD2B409SXPD2B410SXPD2B411

Dyed

Spiral PGA-PCLMH, 36 mm, 1/2 CircleTaper Point

5 x 514 x 14

14 x 1436 x 36

SXMD2B400SXMD2B401

Undyed

Spiral PGA-PCLFS-2, 19 mm, 3/8 CircleReverse Cutting

5 x 512 x 12

14 x 1430 x 30

SXMD2B407SXMD2B409

SXMD2B406SXMD2B408

Undyed

Spiral PGA-PCLFS, 26 mm, 3/8 CircleReverse Cutting

5 x 512 x 12

14 x 1430 x 30 SXMD2B413

SXMD2B411SXMD2B412

Undyed

Spiral PGA-PCLFS-1, 24 mm, 3/8 CircleReverse Cutting

12 x 12 30 x 30 SXMD2B150 SXMD2B410 Undyed

VENTRAL HERNIA

Page 25: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

25

Table of Contents

INGUINAL HERNIORRHAPHY (TAPP - LAPAROSCOPIC OR ROBOTIC)

Peritoneum

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral PDS PlusCT-1, 36 mm, 1/2 CircleTaper Point

612

1530

SXPP1B409 SXPP1B406SXPP1B450

Dyed

Spiral PDS PlusCT-2, 26 mm, 1/2 Circle Taper Point

6 15 SXPP1B413 Dyed

Spiral PDS PlusSH, 26 mm, 1/2 CircleTaper Point

6 15 SXPP1B420 Dyed

Spiral PDS PlusSH-1, 22 mm, 1/2 CircleTaper Point

9 22 SXPP1B453 Dyed

Spiral MONOCRYL Plus

CT-1, 36 mm, 1/2 CircleTaper Point

6 15 SXMP1B411 Undyed

Spiral MONOCRYL Plus

CT-2, 26 mm, 1/2 CircleTaper Point

6 15 SXMP1B415 Undyed

Spiral MONOCRYL Plus

SH, 26 mm, 1/2 CircleTaper Point

9 23 SXMP1B427 SXMP1B409 Undyed

Spiral PDOV-26, 26 mm, 3/8 CircleTAPERCUT® Surgical Needle

9 x 9 24 x 24 SXPD2B424 Dyed

VENTRAL HERNIA (LAPAROSCOPIC OR ROBOTIC)

Fascia

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Symmetric PDS Plus

CT, 40 mm, 1/2 CircleTaper Point

18 45 SXPP1A406 SXPP1A405 Dyed

Symmetric PDS Plus

CT-1, 36 mm, 1/2 CircleTaper Point

18 45 SXPP1A401 SXPP1A404 Dyed

Spiral Polypropylene

CT-3, 22 mm, 1/2 CircleTaper Point

5 x 5 14 x 14 SXPL2B401 Undyed

Spiral Polypropylene

CT-1, 36 mm, 1/2 CircleTaper Point

9 x 9 24 x 24 SXPL2B400 Undyed

Page 26: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

26

Table of Contents

Mesh Fixation

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral Polypropylene

SH-1, 22 mm, 1/2 CircleTaper Point

12 30 SXPL1B400 Undyed

Spiral Polypropylene

CT-3, 22 mm, 1/2 CircleTaper Point

5 x 5 14 x 14 SXPL2B401 Undyed

Spiral Polypropylene

CT-1, 36 mm, 1/2 CircleTaper Point

9 x 9 24 x 24 SXPL2B400 Undyed

VENTRAL HERNIA (LAPAROSCOPIC OR ROBOTIC)

Page 27: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

27

Table of Contents

HPBHPB (OPEN)

Fascia

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Symmetric PDS Plus

CT, 40 mm, 1/2 CircleTaper Point

18 45 SXPP1A406 SXPP1A405 Dyed

Symmetric PDS Plus

CTX, 48 mm, 1/2 CircleTaper Point

18 45 SXPP1A402 SXPP1A400 Dyed

Symmetric PDS Plus

CTXB, 48 mm, 1/2 CircleBlunt Point,ETHIGUARD®Safety Needle

18 45 SXPP1A302 SXPP1A300 Dyed

Symmetric PDS Plus

CT-1, 36 mm, 1/2 CircleTaper Point

18 45 SXPP1A401 SXPP1A404 Dyed

Symmetric PDS Plus

CTB-1, 36 mm, 1/2 CircleBlunt Point,ETHIGUARDSafety Needle

18 45 SXPP1A301 Dyed

Subcutaneous

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral MONOCRYL Plus

SH, 26 mm, 1/2 CircleTaper Point

9 23 SXMP1B409 Undyed

Spiral MONOCRYL Plus

CT-1, 36 mm, 1/2 CircleTaper Point

1218

3045

SXMP1B412SXMP1B413

Undyed

Spiral MONOCRYL Plus

CT-2, 26 mm, 1/2 CircleTaper Point

18 45 SXMP1B417 Undyed

Spiral PDS PlusCT-1, 36 mm, 1/2 CircleTaper Point

1827

4570

SXPP1B411SXPP1B412

Dyed

Spiral PDS PlusSH, 26 mm, 1/2 CircleTaper Point

1227

3070

SXPP1B416SXPP1B417

Dyed

Spiral PDOMH, 36 mm, 1/2 Circle Taper Point

5 x 59 x 9

12 x 1214 x 14

14 x 1424 x 2430 x3036 x 36

SXPD2B407SXPD2B408

SXPD2B412

SXPD2B409SXPD2B410SXPD2B411

Dyed

Spiral PGA-PCLMH, 36 mm, 1/2 CircleTaper Point

5 x 514 x 14

14 x 1436 x 36

SXMD2B400SXMD2B401

Undyed

Page 28: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

28

Table of Contents

HPB (OPEN)

Subcuticular

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral MONOCRYL Plus

PS-1, 24 mm, 3/8 Circle Reverse Cutting

121824

304560

SXMP1B101SXMP1B102SXMP1B103

Undyed

Spiral MONOCRYL Plus

PS-2, 19 mm, 3/8 Circle Reverse Cutting

12182427

30456070

SXMP1B117SXMP1B118

SXMP1B119

SXMP1B106SXMP1B107SXMP1B108

Undyed

Spiral PGA-PCLFS, 26 mm, 3/8 CircleReverse Cutting

5 x 512 x 12

14 x 1430 x 30 SXMD2B413

SXMD2B411SXMD2B412

Undyed

Spiral PGA-PCLFS-2, 19 mm, 3/8 CircleReverse Cutting

5 x 512 x 12

14 x 1430 x 30

SXMD2B407SXMD2B409

SXMD2B406SXMD2B408

Undyed

Spiral PGA-PCLFS-1, 24 mm, 3/8 CircleReverse Cutting

12 x 12 30 x 30 SXMD2B150 SXMD2B410 Undyed

Page 29: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

29

Table of Contents

OB/GYNC-SECTION

Fascia

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Symmetric PDS Plus

CT-1, 36 mm, 1/2 CircleTaper Point

18 45 SXPP1A401 SXPP1A404 Dyed

Symmetric PDS Plus

CT, 40 mm, 1/2 CircleTaper Point

18 45 SXPP1A406 SXPP1A405 Dyed

Symmetric PDS Plus

CTXB, 48 mm, 1/2 CircleBlunt point,ETHIGUARD®Safety Needle

18 45 SXPP1A302 SXPP1A300 Dyed

Symmetric PDS Plus

CTX, 48 mm, 1/2 CircleTaper Point

18 45 SXPP1A402 SXPP1A400 Dyed

Symmetric PDS Plus

CTB-1, 36 mm, 1/2 CircleBlunt point,ETHIGUARDSafety Needle

18 45 SXPP1A301 Dyed

Uterus

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Symmetric PDS Plus

CT-1, 36 mm, 1/2 CircleTaper Point

18 45 SXPP1A403 SXPP1A401 Dyed

Symmetric PDS Plus

CT, 40 mm, 1/2 CircleTaper Point

18 45 SXPP1A406 Dyed

Symmetric PDS Plus

CT-2, 26 mm, 1/2 CircleTaper Point

18 45 SXPP1A407 Dyed

Spiral PDS PlusCTX, 48mm, 1/2 Circle Taper Point

27 70 SXPP1B401 Dyed

Spiral PDS PlusCT-1, 36 mm, 1/2 CircleTaper Point

61218

153045

SXPP1B409SXPP1B410SXPP1B411

Dyed

Spiral MONOCRYL Plus

CT-1, 36 mm, 1/2 CircleTaper Point

121827

304570

SXMP1B412SXMP1B413SXMP1B414

Undyed

Spiral PDOMH, 36 mm, 1/2 CircleTaper Point

5 x 59 x 9

12 x 12

14 x 1424 x 2430 x 30

SXPD2B409SXPD2B410 SXPD2B411

Dyed

Spiral PDOCT-1, 36 mm, 1/2 CircleTaper Point

12 x 12 30 x 30 SXPD2B403 Dyed

Page 30: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

30

Table of Contents

C-SECTION

Peritoneum

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral MONOCRYL Plus

CT-2, 26 mm, 1/2 CircleTaper Point

612

1530

SXMP1B415SXMP1B416

Undyed

Spiral MONOCRYL Plus

SH, 26 mm, 1/2 CircleTaper Point

9 23 SXMP1B427 SXMP1B409 Undyed

Spiral MONOCRYL Plus

CT-1, 36 mm, 1/2 CircleTaper Point

18 45 SXMP1B429 SXMP1B413 Undyed

Spiral PGA-PCLMH, 36 mm, 1/2 CircleTaper Point

5 x 514 x 14

14 x 1436 x 36

SXMD2B400SXMD2B401

Undyed

Subcutaneous

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Symmetric PDS Plus

CT-1, 36 mm, 1/2 CircleTaper Point

18 45 SXPP1A403 Dyed

Spiral PDS PlusCT-1, 36 mm, 1/2 CircleTaper Point

61218

153045

SXPP1B409SXPP1B410SXPP1B411

Dyed

Spiral PDS PlusCP-2, 26 mm, 1/2 CircleTaper Point

18 45 SXPP1B403 Dyed

Spiral MONOCRYL Plus

SH, 26 mm, 1/2 CircleTaper Point

9 23 SXMP1B409 Undyed

Spiral MONOCRYL Plus

CT-1, 36 mm, 1/2 CircleTaper Point

18 45 SXMP1B413 Undyed

Spiral MONOCRYL Plus

RB-1, 17 mm, 1/2 CircleTaper Point

612

1530

SXMP1B424SXMP1B425

Undyed

Spiral MONOCRYL Plus

PS-2, 19 mm, 3/8 CircleReverse Cutting

12182427

30456070

SXMP1B117SXMP1B118

SXMP1B119

SXMP1B106SXMP1B107 SXMP1B108

Undyed

Spiral MONOCRYL Plus

PS-1, 24 mm, 3/8 CircleReverse Cutting

121824

304560

SXMP1B101SXMP1B102SXMP1B103

Undyed

Page 31: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

31

Table of Contents

Subcutaneous

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral PDOMH, 36 mm, 1/2 CircleTaper Point

5 x 59 x 9

12 x 1214 x 14

14 x 1424 x 2430 x 3036 x 36

SXPD2B407SXPD2B408

SXPD2B412

SXPD2B409SXPD2B410SXPD2B411

Dyed

Spiral PGA-PCLMH, 36 mm, 1/2 CircleTaper Point

5 x 514 x 14

14 x 1436 x 36

SXMD2B400SXMD2B401

Undyed

Spiral PGA-PCLFS-2, 19 mm, 3/8 CircleReverse Cutting

5 x 512 x 12

14 x 1430 x 30

SXMD2B407SXMD2B409

SXMD2B406SXMD2B408

Undyed

Spiral PGA-PCLFS, 26 mm, 3/8 CircleReverse Cutting

5 x 512 x 12

14 x 1430 x 30 SXMD2B413

SXMD2B411SXMD2B412

Undyed

Spiral PGA-PCLFS-1, 24 mm, 3/8 CircleReverse Cutting

12 x 12 30 x 30 SXMD2B150 SXMD2B410 Undyed

HYSTERECTOMY (OPEN)

Vaginal Cuff

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Symmetric PDS Plus

CT-1, 36 mm, 1/2 CircleTaper Point

18 45 SXPP1A403 SXPP1A401 Dyed

Symmetric PDS Plus

CT-2, 26 mm, 1/2 CircleTaper Point

18 45 SXPP1A408 SXPP1A407 Dyed

Spiral PDS PlusV-34, 36 mm, 1/2 CircleTAPERCUT® Surgical Needle

12 30 SXPP1B404 Dyed

Spiral PDS PlusCT-1, 36 mm, 1/2 CircleTaper Point

612

1530

SXPP1B409SXPP1B410

Dyed

Spiral PDS PlusV-7, 26 mm, 1/2 CircleTAPERCUT Needle

12 30 SXPP1B418 Dyed

Spiral MONOCRYL Plus

SH, 26 mm, 1/2 CircleTaper Point

9 23 SXMP1B409 Undyed

Spiral MONOCRYL Plus

CT-1, 36 mm, 1/2 CircleTaper Point

18 45 SXMP1B413 Undyed

C-SECTION

Page 32: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

32

Table of Contents

Vaginal Cuff

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral PDOCT-3, 22 mm, 1/2 CircleTaper Point

5 x 5 14 x 14 SXPD2B404 Dyed

Spiral PDOMH, 36 mm, 1/2 CircleTaper Point

3 x 35 x 5

7 x 714 x 14

SXPD2B406SXPD2B407 SXPD2B409

Dyed

Spiral PDOCT-1, 36 mm, 1/2 CircleTaper Point

5 x 5 14 x 14 SXPD2B401 Dyed

Spiral PDOSH, 26 mm, 1/2 CircleTaper Point

4 x 45 x 5

10 x 1014 x 14

SXPD2B413SXPD2B414

Dyed

Spiral PGA-PCLMH, 36 mm, 1/2 Circle Taper Point

5 x 5 14 x 14 SXMD2B400 Undyed

Fascia

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Symmetric PDS Plus

CTX, 48 mm, 1/2 CircleTaper Point

18 45 SXPP1A402 SXPP1A400 Dyed

Symmetric PDS Plus

CT, 40 mm, 1/2 CircleTaper Point

18 45 SXPP1A406 SXPP1A405 Dyed

Symmetric PDS Plus

CTXB, 48 mm, 1/2 CircleBlunt Point,ETHIGUARD®Safety Needle

18 45 SXPP1A302 SXPP1A300 Dyed

Symmetric PDS Plus

CT-1, 36 mm, 1/2 CircleTaper Point

18 45 SXPP1A401 SXPP1A404 Dyed

Symmetric PDS Plus

CTB-1, 36 mm, 1/2 CircleBlunt Point,ETHIGUARDSafety Needle

18 45 SXPP1A301 Dyed

HYSTERECTOMY (OPEN)

Page 33: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

33

Table of Contents

Subcutaneous

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Symmetric PDS Plus

CT-1, 36 mm, 1/2 CircleTaper Point

18 45 SXPP1A403 Dyed

Spiral PDS PlusCT-1, 36 mm, 1/2 CircleTaper Point

61218

153045

SXPP1B409SXPP1B410SXPP1B411

Dyed

Spiral MONOCRYL Plus

SH, 26 mm, 1/2 CircleTaper Point

9 23 SXMP1B409 Undyed

Spiral MONOCRYL Plus

CT-1, 36 mm, 1/2 CircleTaper Point

18 45 SXMP1B413 Undyed

Spiral MONOCRYL Plus

RB-1, 17 mm, 1/2 CircleTaper Point

612

1530

SXMP1B424SXMP1B425

Undyed

Spiral MONOCRYL Plus

PS-2, 19 mm, 3/8 CircleReverse Cutting

121827

304570

SXMP1B117SXMP1B118SXMP1B119

SXMP1B106SXMP1B107SXMP1B108

Undyed

Spiral MONOCRYL Plus

PS-1, 24 mm, 3/8 CircleReverse Cutting

121824

304560

SXMP1B101SXMP1B102SXMP1B103

Undyed

Spiral PDOMH, 36 mm, 1/2 CircleTaper Point

5 x 59 x 9

12 x 1214 x 14

14 x 1424 x 2430 x 3036 x 36

SXPD2B407SXPD2B408

SXPD2B412

SXPD2B409SXPD2B410SXPD2B411

Dyed

Spiral PGA-PCLMH, 36 mm, 1/2 CircleTaper Point

5 x 514 x 14

14 x 1436 x 36

SXMD2B400SXMD2B401

Undyed

Spiral PGA-PCLFS-2, 19 mm, 3/8 CircleReverse Cutting

5 x 512 x 12

14 x 1430 x 30

SXMD2B407SXMD2B409

SXMD2B406SXMD2B408

Undyed

Spiral PGA-PCLFS, 26 mm, 3/8 CircleReverse Cutting

5 x 512 x 12

14 x 1430 x 30 SXMD2B413

SXMD2B411SXMD2B412

Undyed

Spiral PGA-PCLFS-1, 24 mm, 3/8 CircleReverse Cutting

12 x 12 30 x 30 SXMD2B150 SXMD2B410 Undyed

HYSTERECTOMY (OPEN)

Page 34: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

34

Table of Contents

HYSTERECTOMY (LAPAROSCOPIC OR ROBOTIC)

Vaginal Cuff

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Symmetric PDS Plus

CT, 40 mm, 1/2 CircleTaper Point

18 45 SXPP1A406 Dyed

Spiral PDS Plus CT-1, 36 mm, 1/2 CircleTaper Point

9 22 SXPP1B456 SXPP1B455 Dyed

Spiral PDS PlusV-34, 36 mm, 1/2 CircleTAPERCUT® Surgical Needle

9 22 SXPP1B458 SXPP1B457 Dyed

MYOMECTOMY (OPEN)

Uterus

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Symmetric PDS Plus

CT-1, 36 mm, 1/2 CircleTaper Point

18 45 SXPP1A403 SXPP1A401 Dyed

Symmetric PDS Plus

CT, 40 mm, 1/2 CircleTaper Point

18 45 SXPP1A406 Dyed

Symmetric PDS Plus

CT-2, 26 mm, 1/2 CircleTaper Point

18 45 SXPP1A407 Dyed

Spiral PDS PlusCP-2, 26 mm, 1/2 Circle Taper Point

18 45 SXPP1B403 Dyed

Spiral PDS PlusCTX, 48mm, 1/2 Circle Taper Point

27 70 SXPP1B401 Dyed

Spiral PDS PlusCT-1, 36 mm, 1/2 CircleTaper Point

61218

153045

SXPP1B409SXPP1B410SXPP1B411

Dyed

Spiral MONOCRYL Plus

CT-1, 36 mm, 1/2 CircleTaper Point

1218

3045

SXMP1B412 SXMP1B413

Undyed

Spiral PDOMH, 36 mm, 1/2 CircleTaper Point

5 x 59 x 9

12 x 12

14 x 1424 x 2430 x 30

SXPD2B409SXPD2B410 SXPD2B411

Dyed

Page 35: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

35

Table of Contents

Fascia

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Symmetric PDS Plus

CT-1, 36 mm, 1/2 CircleTaper Point

18 45 SXPP1A401 SXPP1A404 Dyed

Symmetric PDS Plus

CT, 40 mm, 1/2 CircleTaper Point

18 45 SXPP1A406 SXPP1A405 Dyed

Symmetric PDS Plus

CTX, 48 mm, 1/2 CircleTaper Point

18 45 SXPP1A402 SXPP1A400 Dyed

Symmetric PDS Plus

CTXB, 48 mm, 1/2 CircleBlunt Point, ETHIGUARD®Safety Needle

18 45 SXPP1A302 SXPP1A300 Dyed

Symmetric PDS Plus

CTB-1, 36 mm, 1/2 CircleBlunt Point, ETHIGUARDSafety Needle

18 45 SXPP1A301 Dyed

Subcutaneous

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral MONOCRYL Plus

SH, 26 mm, 1/2 CircleTaper Point

9 23 SXMP1B409 Undyed

Spiral MONOCRYL Plus

RB-1, 17 mm, 1/2 CircleTaper Point

12 30 SXMP1B425 Undyed

Spiral MONOCRYL Plus

PS-2, 19 mm, 3/8 CircleReverse Cutting

182427

456070

SXMP1B118

SXMP1B119

SXMP1B107SXMP1B108 Undyed

Spiral PDOMH, 36 mm, 1/2 CircleTaper Point

5 x 59 x 9

12 x 1214 x 14

14 x 1424 x 2430 x 3036 x 36

SXPD2B407SXPD2B408

SXPD2B412

SXPD2B409SXPD2B410SXPD2B411

Dyed

Spiral PGA-PCLMH, 36 mm, 1/2 CircleTaper Point

5 x 514 x 14

14 x 1436 x 36

SXMD2B400SXMD2B401

Undyed

MYOMECTOMY (OPEN)

Page 36: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

36

Table of Contents

Uterus

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Symmetric PDS Plus

CT-1, 36 mm, 1/2 CircleTaper Point

18 45 SXPP1A403 SXPP1A401 Dyed

Symmetric PDS Plus

CT, 40 mm, 1/2 CircleTaper Point

18 45 SXPP1A406 Dyed

Symmetric PDS Plus

CT-2, 26 mm, 1/2 CircleTaper Point

18 45 SXPP1A407 Dyed

Spiral PDS PlusV-34, 36 mm, 1/2 CircleTAPERCUT® Surgical Needle

12 30 SXPP1B404 Dyed

Spiral PDS PlusCT-1, 36 mm, 1/2 CircleTaper Point

612

1530

SXPP1B409SXPP1B410

Dyed

Spiral PDS PlusV-7, 26 mm, 1/2 CircleTAPERCUT Needle

12 30 SXPP1B418 Dyed

Spiral MONOCRYL Plus

CT-1, 36 mm, 1/2 CircleTaper Point

18 45 SXMP1B413 Undyed

Spiral MONOCRYL Plus

PS-1, 24 mm, 3/8 CircleReverse Cutting

12 30 SXMP1B101 Undyed

Spiral MONOCRYL Plus

PS-2, 19 mm, 3/8 CircleReverse Cutting

27 70 SXMP1B119 Undyed

Spiral PDOMH, 36 mm, 1/2 CircleTaper Point

3 x 35 x 5

7 x 714 x 14

SXPD2B406SXPD2B407 SXPD2B409

Dyed

Spiral PDOCT-3, 22 mm, 1/2 CircleTaper Point

5 x 5 14 x 14 SXPD2B404 Dyed

Spiral PDOCT-1, 36 mm, 1/2 CircleTaper Point

5 x 5 14 x 14 SXPD2B401 Dyed

Spiral PDOSH, 26 mm, 1/2 CircleTaper Point

4 x 45 x 5

10 x 1014 x 14

SXPD2B413SXPD2B414

Dyed

MYOMECTOMY (LAPAROSCOPIC OR ROBOTIC)

Page 37: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

37

Table of Contents

OrthopedicsHIP

Capsule/Fascia

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Symmetric PDS Plus

CT-1, 36 mm, 1/2 CircleTaper Point

18 45 SXPP1A403 SXPP1A401 SXPP1A404 Dyed

Symmetric PDS Plus

CT, 40 mm, 1/2 CircleTaper Point

18 45 SXPP1A406 SXPP1A405 Dyed

Subcutaneous

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Symmetric PDS Plus

CT-1, 36 mm, 1/2 CircleTaper Point

18 45 SXPP1A403 Dyed

Spiral PDS PlusCT-1, 36 mm, 1/2 CircleTaper Point

6121827

15304570

SXPP1B409SXPP1B410SXPP1B411

SXPP1B406SXPP1B450 SXPP1B429

SXPP1B430SXPP1B431

Dyed

Spiral PDS PlusOS-6, 36 mm, 1/2 CircleReverse Cutting

18 45 SXPP1B201 Dyed

Spiral MONOCRYL Plus

PS-1, 24 mm, 3/8 CircleReverse Cutting

121824

304560

SXMP1B101SXMP1B102SXMP1B103

Undyed

Spiral MONOCRYL Plus

PS-2, 19 mm, 3/8 CircleReverse Cutting

121824

304560

SXMP1B106SXMP1B107SXMP1B108

Undyed

Spiral MONOCRYL Plus

SH, 26 mm, 1/2 CircleTaper Point

9 23 SXMP1B409 Undyed

Spiral MONOCRYL Plus

CT-1, 36 mm, 1/2 CircleTaper Point

1218

3045

SXMP1B412SXMP1B413

Undyed

Spiral MONOCRYL Plus

CT-2, 26 mm, 1/2 CircleTaper Point

18 45 SXMP1B417 Undyed

Spiral PDOMH, 36 mm, 1/2 CircleTaper Point

5 x 59 x 9

12 x 1214 x 14

14 x 1424 x 2430 x 3036 x 36

SXPD2B407SXPD2B408

SXPD2B412

SXPD2B409SXPD2B410SXPD2B411

Dyed

Spiral PGA-PCLMH, 36 mm, 1/2 Circle Taper Point

5 x 514 x 14

14 x 1436 x 36

SXMD2B400SXMD2B401

Undyed

Page 38: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

38

Table of Contents

HIP

Subcuticular

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral MONOCRYL Plus

PS-2, 19 mm, 3/8 CircleReverse Cutting

121827

304570

SXMP1B117SXMP1B118SXMP1B119

SXMP1B107 Undyed

Spiral MONOCRYL Plus

PS-1, 24 mm, 3/8 CircleReverse Cutting

18 45 SXMP1B102 Undyed

Spiral PGA-PCLFS, 26 mm, 3/8 CircleReverse Cutting

5 x 512 x 12

14 x 1430 x 30 SXMD2B413

SXMD2B411SXMD2B412

Undyed

Spiral PGA-PCLFS-2, 19 mm, 3/8 CircleReverse Cutting

5 x 512 x 12

14 x 1430 x 30

SXMD2B407SXMD2B409

SXMD2B406SXMD2B408

Undyed

Spiral PGA-PCLFS-1, 24 mm, 3/8 CircleReverse Cutting

12 x 12 30 x 30 SXMD2B150 SXMD2B410 Undyed

TOTAL KNEE REPLACEMENT

Capsule/Fascia

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Symmetric PDS Plus

CT-1, 36 mm, 1/2 CircleTaper Point

18 45 SXPP1A403 SXPP1A401 SXPP1A404 Dyed

Symmetric PDS Plus

CT, 40 mm, 1/2 CircleTaper Point

18 45 SXPP1A406 SXPP1A405 Dyed

Symmetric PDS Plus

CTX, 48 mm, 1/2 CircleTaper Point

18 45 SXPP1A402 SXPP1A400 Dyed

Symmetric PDS Plus

CTXB, 48 mm, 1/2 CircleBlunt Point,ETHIGUARD®Safety Needle

18 45 SXPP1A302 SXPP1A300 Dyed

Symmetric PDS Plus

CTB-1, 36 mm, 1/2 CircleBlunt Point,ETHIGUARDSafety Needle

18 45 SXPP1A301 Dyed

Page 39: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

39

Table of Contents

Subcutaneous

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Symmetric PDS Plus

CT-1, 36 mm, 1/2 CircleTaper Point

18 45 SXPP1A403 Dyed

Spiral PDS PlusCT-1, 36 mm, 1/2 CircleTaper Point

6121827

15304570

SXPP1B409SXPP1B410SXPP1B411

SXPP1B406SXPP1B450 SXPP1B429

SXPP1B430SXPP1B431

Dyed

Spiral PDS PlusPS-4, 16 mm, 1/2 CircleReverse Cutting

18 45 SXPP1B119 Dyed

Spiral PDS PlusX-1, 22 mm, 1/2 CircleReverse Cutting

28 70 SXPP1B120 Dyed

Spiral PDS PlusSH-1, 22 mm, 1/2 CircleTaper Point

9 22 SXPP1B454 Dyed

Spiral PDS PlusOS-6, 36 mm, 1/2 CircleReverse Cutting

1827

4570

SXPP1B201SXPP1B203

Dyed

Spiral PDS PlusOS-8, 40 mm, 1/2 CircleReverse Cutting

27 70 SXPP1B204 Dyed

Spiral PDS PlusMO-4, 36 mm, 1/2 CircleTaper Point

27 70 SXPP1B205 Dyed

Spiral PDS PlusCTX, 48 mm, 1/2 CircleTaper Point

27 70 SXPP1B401 Dyed

Spiral MONOCRYL Plus

PS-1, 24 mm, 3/8 CircleReverse Cutting

121824

304560

SXMP1B101SXMP1B102SXMP1B103

Undyed

Spiral MONOCRYL Plus

PS-2, 19 mm, 3/8 CircleReverse Cutting

121824

304560

SXMP1B106SXMP1B107SXMP1B108

Undyed

Spiral MONOCRYL Plus

SH, 26 mm, 1/2 CircleTaper Point

9 23 SXMP1B409 Undyed

Spiral MONOCRYL Plus

CT-1, 36 mm, 1/2 CircleTaper Point

1218

3045

SXMP1B412SXMP1B413

Undyed

Spiral MONOCRYL Plus

CT-2, 26 mm, 1/2 CircleTaper Point

18 45 SXMP1B417 Undyed

Spiral PDOMH, 36 mm, 1/2 CircleTaper Point

5 x 59 x 9

12 x 1214 x 14

14 x 1424 x 2430 x 3036 x 36

SXPD2B407SXPD2B408

SXPD2B412

SXPD2B409SXPD2B410SXPD2B411

Dyed

Spiral PGA-PCLMH, 36 mm, 1/2 CircleTaper Point

5 x 514 x 14

14 x 1436 x 36

SXMD2B400SXMD2B401

Undyed

TOTAL KNEE REPLACEMENT

Page 40: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

40

Table of Contents

Subcuticular

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral MONOCRYL Plus

PS-2, 19 mm, 3/8 CircleReverse Cutting

18 45 SXMP1B107 Undyed

Spiral MONOCRYL Plus

PS-1, 24 mm, 3/8 CircleReverse Cutting

18 45 SXMP1B102 Undyed

LAMINOTOMY/LAMINECTOMY

Fascia

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Symmetric PDS Plus

CT-1, 36 mm, 1/2 CircleTaper Point

18 45 SXPP1A401 SXPP1A404 Dyed

Symmetric PDS Plus

CT, 40 mm, 1/2 CircleTaper Point

18 45 SXPP1A406 SXPP1A405 Dyed

Symmetric PDS Plus

CTX, 48 mm, 1/2 CircleTaper Point

18 45 SXPP1A402 SXPP1A400 Dyed

Symmetric PDS Plus

CTXB, 48 mm, 1/2 CircleBlunt Point,ETHIGUARD®Safety Needle

18 45 SXPP1A302 SXPP1A300 Dyed

Symmetric PDS Plus

CTB-1, 36 mm, 1/2 CircleBlunt Point,ETHIGUARDSafety Needle

18 45 SXPP1A301 Dyed

Subcutaneous

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Symmetric PDS Plus

CT-1, 36 mm, 1/2 CircleTaper Point

18 45 SXPP1A403 Dyed

Spiral PDS PlusCT-1, 36 mm, 1/2 CircleTaper Point

61218

153045

SXPP1B409SXPP1B410SXPP1B411

SXPP1B406SXPP1B450 Dyed

Spiral MONOCRYL Plus

PS-1, 24 mm, 3/8 CircleReverse Cutting

121824

304560

SXMP1B101SXMP1B102SXMP1B103

Undyed

Spiral MONOCRYL Plus

PS-2, 19 mm, 3/8 CircleReverse Cutting

121824

304560

SXMP1B106SXMP1B107SXMP1B108

Undyed

TOTAL KNEE REPLACEMENT

Page 41: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

41

Table of Contents

Subcutaneous

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral MONOCRYL Plus

SH, 26 mm, 1/2 CircleTaper Point

9 23 SXMP1B409 Undyed

Spiral MONOCRYL Plus

CT-1, 36 mm, 1/2 CircleTaper Point

1218

3045

SXMP1B412SXMP1B413

Undyed

Spiral MONOCRYL Plus

CT-2, 26 mm, 1/2 CircleTaper Point

18 45 SXMP1B417 Undyed

Spiral PDOMH, 36 mm, 1/2 CircleTaper Point

5 x 59 x 9

12 x 1214 x 14

14 x 1424 x 2430 x 3036 x 36

SXPD2B407SXPD2B408

SXPD2B412

SXPD2B409SXPD2B410SXPD2B411

Dyed

Spiral PGA-PCLMH, 36 mm, 1/2 CircleTaper Point

5 x 514 x 14

14 x 1436 x 36

SXMD2B400SXMD2B401

Undyed

Spiral PGA-PCLFS, 26 mm, 3/8 CircleReverse Cutting

5 x 512 x 12

14 x 1430 x 30 SXMD2B413

SXMD2B411SXMD2B412

Undyed

Spiral PGA-PCLFS-2, 19 mm, 3/8 CircleReverse Cutting

5 x 512 x 12

14 x 1430 x 30

SXMD2B407SXMD2B409

SXMD2B406SXMD2B408

Undyed

Spiral PGA-PCLFS-1, 24 mm, 3/8 CircleReverse Cutting

12 x 12 30 x 30 SXMD2B150 SXMD2B410 Undyed

LAMINOTOMY/LAMINECTOMY

Page 42: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

42

Table of Contents

PlasticsABDOMINOPLASTY

Plication

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Symmetric PDS Plus

CT-1, 36 mm, 1/2 CircleTaper Point

18 45 SXPP1A401 SXPP1A404 Dyed

Symmetric PDS Plus

CTX, 48 mm, 1/2 CircleTaper Point

18 45 SXPP1A402 SXPP1A400 Dyed

Spiral PDS PlusCT-1, 36 mm, 1/2 CircleTaper Point

1218

3045

SXPP1B429 SXPP1B430

Dyed

Spiral PDOMH, 36 mm, 1/2 CircleTaper Point

12 x 129 x 9

30 x 3024 x 24

SXPD2B411SXPD2B410

Dyed

Spiral PDOCT-1, 36 mm, 1/2 CircleTaper Point

9 x 912 x 12

24 x 2430 x 30

SXPD2B402SXPD2B403

Dyed

Spiral PDOCTX, 48 mm, 1/2 CircleTaper Point

14 x 14 36 x 36 SXPD2B405 Dyed

Spiral PDOMO-4, 36 mm, 1/2 CircleTaper Point

14 x 14 36 x 36 SXPD2B400 Dyed

SpiralPolypropylene

CT-1, 36 mm, 1/2 CircleTaper Point

9 x 9 24 x 24 SXPL2B400 Undyed

ABDOMINOPLASTY/BREAST

Superficial Fascial System (SFS)

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral PDOMH, 36 mm, 1/2 CircleTaper Point

9 x 912 x 1214 x 14

24 x 2430 x 3036 x 36

SXPD2B408

SXPD2B412

SXPD2B410SXPD2B411 Dyed

Page 43: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

43

Table of Contents

ABDOMINOPLASTY/BREAST

Subcutaneous

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Symmetric PDS Plus

CT-1, 36 mm, 1/2 CircleTaper Point

18 45 SXPP1A403 Dyed

Symmetric PDS Plus

CT-2, 26 mm, 1/2 CircleTaper Point

18 45 SXPP1A408 Dyed

Symmetric PDS Plus

SH, 26 mm, 1/2 CircleTaper Point

18 45 SXPP1A410 Dyed

Symmetric PDS Plus

PS-2, 19 mm, 3/8 Circle Reverse Cutting

18 45 SXPP1A101 Dyed

Symmetric PDS Plus

PS-1, 24 mm, 3/8 Circle Reverse Cutting

18 45 SXPP1A100 Dyed

Spiral MONOCRYL Plus

CT-1, 36 mm, 1/2 CircleTaper Point

18 45 SXMP1B429 SXMP1B413 Undyed

Spiral MONOCRYL Plus

PS-1, 24 mm, 3/8 Circle Reverse Cutting

1224

3060

SXMP1B101SXMP1B103

Undyed

Spiral MONOCRYL Plus

PS-2, 19 mm, 3/8 Circle Reverse Cutting

122427

306070

SXMP1B117

SXMP1B119

SXMP1B106SXMP1B108 Undyed

Spiral PDS PlusPS-2, 19 mm, 3/8 Circle Reverse Cutting

18 45 SXPP1B113 SXPP1B105 Dyed

Spiral PDS PlusSH-1, 22 mm, 1/2 CircleTaper Point

9 22 SXPP1B454 SXPP1B453 Dyed

Spiral PDS PlusPS-4, 16 mm, 1/2 CircleReverse Cutting

18 45 SXPP1B119 Dyed

Spiral PDOFS, 26 mm, 3/8 Circle Reverse Cutting

9 x 9 24 x 24 SXPD2B419 Dyed

Spiral PGA-PCLFS-2, 19 mm, 3/8 CircleReverse Cutting

12 x 12 30 x 30 SXMD2B409 SXMD2B408 Undyed

Spiral PGA-PCLFS-1, 24 mm, 3/8 CircleReverse Cutting

12 x 12 30 x 30 SXMD2B150 SXMD2B410 Undyed

Spiral PGA-PCLFS, 26 mm, 3/8 CircleReverse Cutting

12 x 12 30 x 30 SXMD2B413 SXMD2B412 Undyed

Spiral PGA-PCLMH, 36 mm, 1/2 CircleTaper Point

14 x 14 36 x 36 SXMD2B401 Undyed

Page 44: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

44

Table of Contents

ABDOMINOPLASTY/BREAST

Subcuticular

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral MONOCRYL Plus

PS-2, 19 mm, 3/8 CircleReverse Cutting

1227

3070

SXMP1B117SXMP1B119

Undyed

Spiral PGA-PCLFS-2, 19 mm, 3/8 CircleReverse Cutting

5 x 512 x 12

14 x 1430 x 30

SXMD2B407SXMD2B409

Undyed

Spiral PGA-PCLFS-1, 24 mm, 3/8 CircleReverse Cutting

12 x 12 30 x 30 SXMD2B150 Undyed

Spiral PGA-PCLFS, 26 mm, 3/8 CircleReverse Cutting

12 x 12 30 x 30 SXMD2B413 Undyed

BREAST

Areola

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral MONOCRYL Plus

SH, 26 mm, 1/2 Circle Taper Point

9 23 SXMP1B427 Undyed

Spiral MONOCRYL Plus

PS-1, 24 mm, 3/8 Circle Reverse Cutting

12 30 SXMP1B101 Undyed

Spiral MONOCRYL Plus

PS-2, 19 mm, 3/8 CircleReverse Cutting

12 30 SXMP1B106 Undyed

Spiral PDS PlusSH-1, 22 mm, 1/2 CircleTaper Point

9 22 SXPP1B454 SXPP1B453 Undyed

Spiral PGA-PCLFS-2, 19 mm, 3/8 CircleReverse Cutting

5 x 5 14 x 14 SXMD2B407 SXMD2B406 Undyed

Spiral PGA-PCLFS, 26 mm, 3/8 CircleReverse Cutting

5 x 5 14 x 14 SXMD2B411 Undyed

Page 45: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

45

Table of Contents

UrologyPROSTATECTOMY

Fascia

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Symmetric PDS Plus

CT-1, 36 mm, 1/2 CircleTaper Point

18 45 SXPP1A401 SXPP1A404 Dyed

Symmetric PDS Plus

CT, 40 mm, 1/2 CircleTaper Point

18 45 SXPP1A406 SXPP1A405 Dyed

Symmetric PDS Plus

CTX, 48 mm, 1/2 CircleTaper Point

18 45 SXPP1A402 SXPP1A400 Dyed

Symmetric PDS Plus

CTXB, 48 mm, 1/2 CircleBlunt point,ETHIGUARD®Safety Needle

18 45 SXPP1A302 SXPP1A300 Dyed

Symmetric PDS Plus

CTB-1, 36 mm, 1/2 CircleBlunt point,ETHIGUARDSafety Needle

18 45 SXPP1A301 Dyed

Peritoneum

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral MONOCRYL Plus

CT-2, 26 mm, 1/2 Circle Taper Point

612

1530

SXMP1B415SXMP1B416

Undyed

Spiral MONOCRYL Plus

SH, 26 mm, 1/2 Circle Taper Point

9 23 SXMP1B427 SXMP1B409 Undyed

Spiral MONOCRYL Plus

CT-1, 36 mm, 1/2 Circle Taper Point

18 45 SXMP1B429 SXMP1B413 Undyed

Spiral PGA-PCLMH, 36 mm, 1/2 Circle Taper Point

5 x 514 x 14

14 x 1436 x 36

SXMD2B400SXMD2B401

Undyed

PROSTATECTOMY

Subcutaneous

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Symmetric PDS Plus

CT-1, 36 mm, 1/2 CircleTaper Point

18 45 SXPP1A403 Dyed

Spiral PDS PlusSH, 26 mm, 1/2 CircleTaper Point

1227

3070

SXPP1B416SXPP1B417

Dyed

Spiral PDS PlusCT-1, 36 mm, 1/2 CircleTaper Point

1827

4570

SXPP1B411SXPP1B412

Dyed

Page 46: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

46

Table of Contents

Subcutaneous

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral PDOMH, 36 mm, 1/2 Circle Taper Point

5 x 59 x 9

12 x 1214 x 14

14 x 1424 x 2430 x 3036 x 36

SXPD2B407SXPD2B408

SXPD2B412

SXPD2B409SXPD2B410SXPD2B411

Dyed

Spiral MONOCRYL Plus

CT-1, 36 mm, 1/2 CircleTaper Point

1218

3045

SXMP1B412SXMP1B413

Undyed

Spiral MONOCRYL Plus

CT-2, 26 mm, 1/2 CircleTaper Point

18 45 SXMP1B417 Undyed

Spiral MONOCRYL Plus

RB-1, 17 mm, 1/2 Circle Taper Point

612

1530

SXMP1B424SXMP1B425

Undyed

Spiral MONOCRYL Plus

SH, 26 mm, 1/2 CircleTaper Point

9 23 SXMP1B409 Undyed

Spiral MONOCRYL Plus

PS-1, 24 mm, 3/8 CircleReverse Cutting

121824

304560

SXMP1B101SXMP1B102SXMP1B103

Undyed

Spiral MONOCRYL Plus

PS-2, 19 mm, 3/8 CircleReverse Cutting

12182427

30456070

SXMP1B117SXMP1B118

SXMP1B119

SXMP1B106SXMP1B107SXMP1B108

Undyed

Spiral PGA-PCLMH, 36 mm, 1/2 Circle Taper Point

5 x 514 x 14

14 x 1436 x 36

SXMD2B400SXMD2B401

Undyed

Spiral PGA-PCLFS-2, 19 mm, 3/8 CircleReverse Cutting

5 x 512 x 12

14 x 1430 x 30

SXMD2B407SXMD2B409

SXMD2B406Undyed

Spiral PGA-PCLFS, 26 mm, 3/8 CircleReverse Cutting

5 x 512 x 12

14 x 1430 x 30 SXMD2B413

SXMD2B411SXMD2B412

Undyed

Spiral PGA-PCLFS-1, 24 mm, 3/8 CircleReverse Cutting

12 x 12 30 x 30 SXMD2B150 SXMD2B410 Undyed

PROSTATECTOMY

Urethrovesical Anastomosis (Bladder-Urethra Anastomosis)

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral PDS PlusCT-1, 36 mm, 1/2 CircleTaper Point

612

1530

SXPP1B409SXPP1B410

SXPP1B406SXPP1B450

Dyed

Spiral PDS PlusCT-2, 26 mm, 1/2 Circle Taper Point

6 15 SXPP1B413 Dyed

Spiral PDS PlusSH, 26 mm, 1/2 CircleTaper Point

6 15 SXPP1B420 Dyed

PROSTATECTOMY

Page 47: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

47

Table of Contents

Urethrovesical Anastomosis (Bladder-Urethra Anastomosis)

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral PDS PlusRB-1, 17 mm, 1/2 CircleTaper Point

6 15 SXPP1B422 Dyed

Spiral MONOCRYL Plus

SH, 26 mm, 1/2 CircleTaper Point

9 23 SXMP1B427 SXMP1B409 Undyed

Spiral PDOCT-3, 22 mm, 1/2 CircleTaper Point

5 x 5 14 x 14 SXPD2B404 Dyed

Spiral PDOMH, 36 mm, 1/2 CircleTaper Point

3 x 35 x 5

7 x 714 x 14

SXPD2B406SXPD2B407 SXPD2B409

Dyed

Spiral PDOSH, 26 mm, 1/2 CircleTaper Point

4 x 45 x 5

10 x 1014 x 14

SXPD2B413SXPD2B414

Dyed

NEPHRECTOMY/PARTIAL NEPHRECTOMY

Organ/Renorrhaphy (Kidney Closure on Partial Nephrectomy)

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral PDS PlusV-34, 36 mm, 1/2 Circle TAPERCUT® Surgical Needle

12 30 SXPP1B404 Dyed

Spiral PDS PlusV-7, 26 mm, 1/2 Circle TAPERCUT Needle

12 30 SXPP1B418 Dyed

Spiral PDS PlusCT-1, 36 mm, 1/2 CircleTaper Point

612

1530

SXPP1B409SXPP1B410

Dyed

Spiral MONOCRYL Plus

CT-1, 36 mm, 1/2 CircleTaper Point

12 30 SXMP1B412 Undyed

Spiral MONOCRYL Plus

SH, 26 mm, 1/2 CircleTaper Point

9 23 SXMP1B409 Undyed

Spiral PDOMH, 36 mm, 1/2 Circle Taper Point

3 x 35 x 5

7 x 714 x 14

SXPD2B406SXPD2B407 SXPD2B409

Dyed

Spiral PDOCT-1, 36 mm, 1/2 CircleTaper Point

5 x 5 14 x 14 SXPD2B401 Dyed

Spiral PDOCT-3, 22 mm, 1/2 CircleTaper Point

5 x 5 14 x 14 SXPD2B404 Dyed

Spiral PDOSH, 26 mm, 1/2 CircleTaper Point

4 x 45 x 5

10 x 1014 x 14

SXPD2B413SXPD2B414

Dyed

PROSTATECTOMY

Page 48: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

48

Table of Contents

Fascia

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Symmetric PDS Plus

CT-1, 36 mm, 1/2 CircleTaper Point

18 45 SXPP1A401 SXPP1A404 Dyed

Symmetric PDS Plus

CT, 40 mm, 1/2 CircleTaper Point

18 45 SXPP1A406 SXPP1A405 Dyed

Symmetric PDS Plus

CTX, 48 mm, 1/2 CircleTaper Point

18 45 SXPP1A402 SXPP1A400 Dyed

Symmetric PDS Plus

CTXB, 48 mm, 1/2 CircleBlunt point,ETHIGUARD®Safety Needle

18 45 SXPP1A302 SXPP1A300 Dyed

Symmetric PDS Plus

CTB-1, 36 mm, 1/2 CircleBlunt point,ETHIGUARDSafety Needle

18 45 SXPP1A301 Dyed

Peritoneum

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral MONOCRYL Plus

CT-2, 26 mm, 1/2 Circle Taper Point

612

1530

SXMP1B415SXMP1B416

Undyed

Spiral MONOCRYL Plus

SH, 26 mm, 1/2 Circle Taper Point

9 23 SXMP1B427 SXMP1B409 Undyed

Spiral MONOCRYL Plus

CT-1, 36 mm, 1/2 Circle Taper Point

18 45 SXMP1B429 SXMP1B413 Undyed

Spiral PGA-PCLMH, 36 mm, 1/2 Circle Taper Point

5 x 514 x 14

14 x 1436 x 36

SXMD2B400SXMD2B401

Undyed

Subcutaneous

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Symmetric PDS Plus

CT-1, 36 mm, 1/2 CircleTaper Point

18 45 SXPP1A403 Dyed

Spiral PDS PlusSH, 26 mm, 1/2 CircleTaper Point

1227

3070

SXPP1B416SXPP1B417

Dyed

Spiral PDS PlusCT-1, 36 mm, 1/2 Circle Taper Point

6121827

15304570

SXPP1B409SXPP1B410SXPP1B411SXPP1B412

Dyed

NEPHRECTOMY/PARTIAL NEPHRECTOMY

Page 49: STRATAFIX Knotless Tissue Control Devices …...References: 1. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs

49

Table of Contents

Subcutaneous

Polymer Needle Length (in)

Length (cm) 4-0 3-0 2-0 0 1 Color

Spiral PDOMH, 36 mm, 1/2 Circle Taper Point

5 x 59 x 9

12 x 1214 x 14

14 x 1424 x 2430 x 3036 x 36

SXPD2B407SXPD2B408

SXPD2B412

SXPD2B409SXPD2B410SXPD2B411

Dyed

Spiral MONOCRYL Plus

SH, 26 mm, 1/2 CircleTaper Point

9 23 SXMP1B409 Undyed

Spiral MONOCRYL Plus

RB-1, 17 mm, 1/2 Circle Taper Point

6 15 SXMP1B424 Undyed

Spiral MONOCRYL Plus

CT-1, 36 mm, 1/2 CircleTaper Point

1218

3045

SXMP1B412SXMP1B413

Undyed

Spiral MONOCRYL Plus

CT-2, 26 mm, 1/2 CircleTaper Point

18 45 SXMP1B417 Undyed

Spiral MONOCRYL Plus

PS-1, 24 mm, 3/8 CircleReverse Cutting

121824

304560

SXMP1B101SXMP1B102SXMP1B103

Undyed

Spiral MONOCRYL Plus

PS-2, 19 mm, 3/8 CircleReverse Cutting

12182427

30456070

SXMP1B117SXMP1B118

SXMP1B119

SXMP1B106SXMP1B107SXMP1B108

Undyed

Spiral PGA-PCLMH, 36 mm, 1/2 Circle Taper Point

5 x 514 x 14

14 x 1436 x 36

SXMD2B400SXMD2B401

Undyed

Spiral PGA-PCLFS, 26 mm, 3/8 CircleReverse Cutting

5 x 512 x 12

14 x 1430 x 30 SXMD2B413

SXMD2B411SXMD2B412

Undyed

Spiral PGA-PCLFS-2, 19 mm, 3/8 CircleReverse Cutting

5 x 512 x 12

14 x 1430 x 30

SXMD2B407SXMD2B409

SXMD2B406SXMD2B408

Undyed

Spiral PGA-PCLFS-1, 24 mm, 3/8 CircleReverse Cutting

12 x 12 30 x 30 SXMD2B150 SXMD2B410 Undyed

For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.

©2017 Ethicon US, LLC. All rights reserved. 044666-170828

NEPHRECTOMY/PARTIAL NEPHRECTOMY