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SYNFIX® EVOLUTION SYSTEM

Implants and Instruments for Stand-alone Anterior Lumbar Interbody Fusion

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SUMMARY

• SYNFIX® Evolution Implants and Instruments: Overview of Features

• Design Rationale

– Biomechanical Stability

– Procedural Efficiencies

– Comprehensive Implant Portfolio

• Surgical Steps

• Triple Aim

• ALIF Evolution Family

• Tips and Tricks

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OVERVIEW of FEATURES

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SYNFIX EVOLUTION IMPLANTS

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SYNFIX EVOLUTION IMPLANTS

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SYNFIX EVOLUTION INSTRUMENTS

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SYNFIX EVOLUTION INSTRUMENTS Evolution SQUID™ Inserter/Distractor Option

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INDICATIONS

The SYNFIX Evolution Secured Spacer

System is a stand-alone anterior interbody

fusion device indicated for use in patients with

degenerative disc disease (DDD) at one or

two contiguous levels from L2 to S1. These

DDD patients may also have up to Grade I

spondylolisthesis at the involved level(s). The

interior of the spacer component of the

SYNFIX Evolution can be packed with

autograft.

DDD is defined as back pain of discogenic

origin with degeneration of the disc confirmed

by history and radiographic studies. These

patients should be skeletally mature and have

had six months of non-operative treatment.

INDICATIONS AND CONTRAINDICATIONS

CONTRAINDICATIONS

1. Use of the SYNFIX Evolution is contraindicated when there is active systemic

infection, infection localized to the site of the proposed implantation, or when the

patient has demonstrated allergy or foreign body sensitivity to any of the implant

materials (PEEK OPTIMA LT-1, Tantalum, Titanium, Aluminum and/or niobium).

2. Severe osteoporosis may prevent adequate fixation and thus preclude the use of

this or any other orthopaedic implant.

3. Conditions that may place excessive stresses on bone and implants, such as

severe obesity or degenerative diseases, are relative contraindications. The

decision whether to use these devices in patients with such conditions must be

made by the physician taking into account the risks versus the benefits to the

patient.

4. Use of these implants is relatively contraindicated in patients whose activity,

mental capacity, mental illness, alcoholism, drug abuse, occupation, or lifestyle

may interfere with their ability to follow postoperative restrictions. These patients

may place undue stresses on the implant during bony healing and may be at a

higher risk of implant failure.

5. Use of the SYNFIX Evolution is contraindicated when patient anatomy or

pathology prevents insertion of all four locking screws.

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DESIGN RATIONALE

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Procedural Efficiencies

Comprehensive Implant Portfolio

DESIGN RATIONALE

Biomechanical Stability

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Procedural Efficiencies

Comprehensive Implant Portfolio

DESIGN RATIONALE

Biomechanical Stability

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BIOMECHANICAL STABILITY Key Features

PEEK ~ Cortical Bone

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BIOMECHANICAL STABILITY* Compared to 360°Fusion

0

1

2

3

4

5

6

7

8

9

Flexion*(6 Nm)

Extension*(6 Nm)

LateralBending*(6 Nm)

AxialRotation**

(6 Nm)

Ra

ng

e o

f M

otio

n (°)

Intact

SYNFIX® LR Implant

360°Fusion

1Cain et al (2005): A new stand-alone ALIF device: Biomechanical comparison with established fixation methods

*Biomechanical test results may not necessarily be indicative of clinical performance

The SYNFIX® LR Implant is equivalent to 360°fusion in flexion,

extenson and lateral bending; superior in axial rotation.1

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BIOMECHANICAL STABILITY* Compared to Competitive Products

3 Variable Angle Screws Medtronic

SOVEREIGN® Interbody Device

Blade Fixation LDR Spine

ROI-A® ALIF Cage

4 Variable Angle Screws Centinel Spine

STALIF TT® Cage

1Freeman et al (2016): Biomechanical comparison of stand-alone anterior lumbar interbody fusion devices

with secured fixation: Four-screw locking plate vs Three-screw variable angle vs. blade fixation 2Schleicher et al (2008) Biomechanical comparison of two different concepts for stand-alone anterior lumbar

interbody fusion

*Biomechanical test results may not necessarily be indicative of clinical performance

The SYNFIX LR Implant demonstrates superior biomechanical

stability compared to other stand-alone ALIF products 1,2

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AO principles Key criterion to promote

bone formation and solid fusion1

BIOMECHANICAL STABILITY Clinical Outcome

1Aebi et al (2007) AOSPINE Manual

2Ardern et al (2008) Clinical and radiological outcomes of stand-alone anterior lumbar interbody fusion used

to treat discogenic pain: Two year results of the SynFix-LR device. 3Siepe et al (2015) Anterior stand-alone fusion revisited: a prospective clinical X-ray and CT investigation

Clinical Experience SYNFIX LR Implant as effective as 360°

fusion in achieving fusion in the

management of discogenic back pain over

one and two levels.2,3

97.3% fusion rate reported with the

SYNFIX LR Implant 3

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Procedural Efficiencies

Comprehensive Implant Portfolio

DESIGN RATIONALE

Biomechanical Stability

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PROCEDURAL EFFICIENCIES Reduced Number of Instrument Passes

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PROCEDURAL EFFICIENCIES Rapid Screw Insertion & Enhanced Design for Surgeon Handling

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PROCEDURAL EFFICIENCIES Minimally Invasive Enabled Anterior Access

Potentially Leading to Reduced Hospital Stay, Blood Loss, Intraoperative Time 1

1Lammli et al (2014) Stand-alone Anterior Lumbar Interbody Fusion for Degenerative Disc Disease of the

Lumbar Spine

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Procedural Efficiencies

Comprehensive Implant Portfolio

DESIGN RATIONALE

Biomechanical Stability

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COMPREHENSIVE IMPLANT PORTFOLIO

6 Footprints

4 Angles 126 Implant Options

6 Heights

18° Medium

36mm x 28mm

10.5mm

12mm

13.5mm

15mm

17mm

19mm

10° 14° 6° Large

40mm x 31mm

Small

32mm x 25mm

Footprints Angles & Heights

Medium Deep

36mm x 31mm

Large Deep

40mm x 34mm

Small Deep

32mm x 28mm

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COMPREHENSIVE IMPLANT PORTFOLIO Support Sagittal Restoration & Maximized Graft Volume

Sagittal Restoration

is correlated with good

clinical outcome1

1Le Huec et al (2014) Evidence showing the relationship between sagittal balance and clinical outcome in

surgical treatment of degenerative spinal diseases: a literature review.

Graft retention ridge Central strut enhances graft fixation

Optimized lumen

design to maximize

graft/fusion volume

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COMPREHENSIVE IMPLANT PORTFOLIO Reduced Risk of Subsidence

R1

R2

R2 > R1

Appropriate choice of

cage footprint

potentially reduces

risk of subsidence 1

S

M

L

SD

MD

LD

1Michaela et al (2008) Footprint mismatch in lumbar total disc arthroplasty

Asymmetrical

anatomic convexity

to fit lumbar and

lumbosacral

endplates

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Fine tip

Dual lead

Cortical thread

Blunt tip

COMPREHENSIVE IMPLANT PORTFOLIO Screws

20 mm, 25 mm and 30 mm

lengths available

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SURGICAL STEPS

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SURGICAL STEPS

Access

Discectomy Trialing

Distraction

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Option B: Evolution

SQUID™ Inserter

SURGICAL STEPS

Implant Preparation

Option A:

Aiming Device

Cage Insertion

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Screw Preparation

SURGICAL STEPS

Pilot Hole Creation

Screw Insertion

Final Tightening

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SURGICAL STEPS

Screw Removal Cage Removal

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TRIPLE AIM

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TRIPLE AIM Strategic Fit of the SYNFIX Evolution System

Primary biomechanical

stability is a key AO

principle for succesfull

fusion

Comprehensive

implant portfolio

delivers solutions for a

wide range of patient

anatomies

Increased procedural

efficiencies targeting less

OR time and reduced

hospital stay

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EVOLUTION FAMILY

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ALIF EVOLUTION FAMILY

SYNCAGE® Evolution SYNFIX Evolution

• SYNFRAME® Access and Retractor

System

• Proprep

• Implant options (footprint, angle, heights)

• Implant convexities

• Evolution SQUID Inserter/Distractor

(Push blocks are system specific)

• Exposure to closure

• PEEK cages

• Anterior and anterolateral access

option

• Additional fixation required

• SYNCAGE® Evolution Trials and

Rasp

• Evolution Trial Spacer and

Implant Holder

• PEEK cage with Titanium

locking plate and screws

• Anterior access option

• Stand-alone

• SYNFIX Evolution Trials

• Aiming Device Holder

• SYNFIX Evolution Trial Implant

Holder

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TIPS AND TRICKS

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AIMING DEVICE ASSEMBLY

• The Coupling uses the same T15 drive feature as the SYNFIX Evolution Screwdriver

• The Coupling is not self retaining

• The Aiming Device cannot be assembled to the Aiming Device Holder if the Coupling is fully

inserted. Therefore make sure the Coupling is removed prior to assembling the Aiming

Device to the Holder.

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AIMING DEVICE ASSEMBLY

• It is recommended that the scrub tech removes the Coupling prior to passing the Aiming

Device Holder to the surgeon. This will minimize inadvertant release of the implant as well as

prevent impaction on the Coupling Screw.

• The Aiming Device Holder can be impacted for implant insertion. Remove the Coupling first!

• 17/19 Aiming Device is a 2 screw Aiming Device, due to the distance between the cranial and

caudal holes on the implant. Rotation of the aiming device is necessary.

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SYNFIX EVOLUTION SCREWDRIVER OPTIONS

• U-joint

• Thread Lock Sleeve (sterile, single use)

• U-joint

• Self retaining

• Straight

• Self retaining

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PROTECTION SLEEVE ASSEMBLY

• For all U-jointed SYNFIX Evolution

Instruments

• Slide the Protection sleeve, with the

arrow pointing to the handle end

• The Protection Sleeve has a pre-

angulation of 35°to facilitate insertion

into the Aiming Device and provides

additional positional memory of the

joint

35°

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THREAD LOCK SLEEVE ASSEMBLY

• Ensure the arrow on the Thread

Lock Sleeve is pointing towards the

Screwdriver handle

• Thread the Thread Lock Sleeve all the

way down on the Screwdriver tip

Note: The Thread Lock Sleeve will float freely on

the Screwdriver tip

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SCREW LOADING WITH THREAD LOCK SLEEVE

• Place a screw in the screw Loading Station with the tip down (1)

• Keep Loading Station and Screwdriver in the vertical position

• Engage the screw with the Screwdriver tip (2)

• Ensure the lobes of the Thread Lock Sleeve are mating with the loading station. It may

be necessary to advance the Sleeve using your finger to engage the screw. (2)

• Use visual aids to ensure the Thread Lock Sleeve is completetly down (3)

• Turn the Screwdriver counter-clockwise until the sleeve is fully seated on the screw

head (two-finger tight) (3)

1 2 3

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• Attach Aiming device

– Optionally detachable Aiming Device Holder

(It is recommended to have one screw inserted before detaching the holder)

• Create pilot hole with awl

• Screw insertion

– Start with the S1 screw in case of L5-S1 segment

– Align the screw with bore in aiming device

– Lobes of Thread Lock Sleeve dock and Thread Lock Sleeve automatically detaches

– Angulation of the U-Joint can make driving the screw challenging, so try and keep the

U-Joint as straight as possible.

• In case you want to remove a screw use one of the Self Retaining Screwdrivers

SCREW INSERTION

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Following complete screw insertion, the screw has to be final tightened with the Torque Limiting Handle

– Option 1 Insert the screw with a Straight Handle for ergonomics and then once all screws are

inserted switch to the Torque Limiting Handle in combination with one of the Self Retaining

Screwdrivers (1) (2)

– Option 2 Insert and final tighten the screw in one step using the Torque Limiting Handle (2)

FINAL TIGHTENING

1 2

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• During final tightening the U-joint should be as straight as possible to ensure good torque

transmission from the handle to the screw.

• Do not cross the Screwdriver over the Aiming Device Holder

• Use the Soft Tissue Retractor to retract soft tissue, so you can reduce U-joint angulation

• Use the lip designed on the Aiming Device to find solid support for the soft tissue retractor

FINAL TIGHTENING

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20°

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30°

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40°

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50°

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60°

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70°

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