Delta System - Stryker MedEd resorbable plates/screws are implanted into patients, their bodies breakdown and remove the polymers through ... 1.7 mm Delta Plates 1.7 mm Resorbable

Delta System Resorbable Implant Technology

For over half a century, Stryker has been developing products based onthe expressed needs of leading practitioners.

A Legacy of Serving theSurgical Community

You will often find a Stryker product specialist speaking with a surgeon, learning and listening. By paying careful attention to the surgeon’s needs, Stryker has been able to refine and augment its products to better serve the surgical community. The all-inclusive color-coded systems of plates and screws make identification easy. Biomaterials and resorbable products for bone repair and reconstruction offer surgeons a range of options as they help renew and rebuild lives. Stryker CMF takes pride in its close relationships with leading surgeons worldwide and has earned a reputation for excellence in the products that serve this collaborative surgeon community. Stryker constantly refines its products and continues focused research in biomaterials, fixation systems and surgical devices.

Our products are derived from a close working collaboration with surgeons, physicians and healthcare experts from the entire spectrum of the healthcare field.

Polymers and Resorbable Systems

Resorbable systems are composed of different blends and ratios of lactide and/or glycolide copolymers, which produce distinguished features and characteristics. These lactide and glycolide polymers are connected through ester bonds to form long chains of polymers (polyesters).1 Once these resorbable plates/screws are implanted into patients, their bodies breakdown and remove the polymers through two processes: hydrolysis and metabolism. Hydrolysis reaction breaks the ester bonds and degrades the polymers into lactic and/or glycolic acids.1 These acidic products from the hydrolysis reaction are then removed and metabolized into glucose, carbon dioxide, or water.1

The strength retention, resorption rate, and biocompatibility of resorbable implants are dependent on multiple factors: the crystalline/amorphous polymer structure, molecular weight, manufacturing process, implant size, patient anatomy/metabolism, and polymer composition.1 Strength retention, resorption rate, and biocompatibility, to an extent, reflect the effectiveness of a resorbable system.

Strength Retention plays an integral role in proper bone healing. For pediatric craniosynostosis cases in particular where there are large bony gaps due to expanded cranial vaults and frontal advancements, it is important for resorbable plates/screws to maintain their strength and structural integrity for a sufficient period of time for new bone formation to occur.1

Resorption Rate, which affects strength retention, is also important. High resorption rates could potentially lead to premature loss of mechanical integrity and to adverse tissue-implant and inflammatory reactions caused by accumulation of polymeric acidic degradation products,2 local sub-physiological low pH gradients,3, 5 and adverse immune/foreign body reactions.4 Inflammatory responses can also occur if the degradation rate is faster than the body’s ability to handle the degradation products.5 Evidence from clinical experience may suggest resorbable implants that degrade at a gradual rate may be more preferred.5

Biocompatibility is, for the most part, determined by resorption rate, mentioned above, and polymer composition. In terms of polymer composition, clinical evidence demonstrates polylactide and polyglycolide polymer blends, in comparison with purely lactide copolymers (PLLA/PDLA), tend to produce better biocompatibility and long-term results.4 However, high ratios of polyglycolide can potentially produce the opposite effect by causing rapid resorption and eliciting inflammatory reactions.4

Delta Polymer

Indications for Use The Delta Resorbable Fixation System is intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients but is not intended for use in the mandible and/or full load bearing procedures Contraindications The Resorbable Implant System is not intended for use in the mandible or other load bearing regions. It is also not intended for regions with: • Active infection • Patient conditions including blood supply limitations, insufficient quality or quantity of bone or latent infection • Mandible or temporal mandibular joint • Full load bearing procedures

Delta has a copolymer composition of poly L-lactide (PLLA), poly D-lactide (PDLA), and polyglycolide (PGA) in a ratio of 85:5:10. It has an attractive combination6 of strength, contourability, and balanced resorption.

Strength Retention: At 2 and 6 months, Delta maintains 78% and 50% of its initial strength respectively,7 which can help facilitate structural fixation and reinforcement during osteosynthesis.

Resorption Rate: The product has a gradual resorption time, depending on the patient anatomy and metabolism, of approximately 18-36 months.8

Biocompatibility: Compared to other resorbable systems containing polyglycolide, Delta has a relatively low ratio of PGA.2 In a clinical study, Delta, in a comparison against two other resorbable systems in terms of complications, incited a relatively mild tissue reaction.9 The authors stated this might have been due to the PLLA/PDLA/PGA ratio of Delta.9

70-05114 14 Hole Straight

70-05168 8 Hole Double-Y70-05166 6 Hole Double-Y

70-05348 24 mm Burr Hole Cover

70-05365 8 Hole Strut Plate 150 x 15 mm

1.7 mm Delta Plates1.7 mm Resorbable Plates

1.7 mm plates and mesh are designed for cranial and frontal non-load bearing applications. The 1.7 mm plates, mesh, and instruments are color coded purple.

1.7

70-05141 7 Hole L-Shape 110˚ L

70-05140 7 Hole L-Shape 110˚ R

70-05330 2 x 5 Hole Ladder 70-05310 4 Hole Box Plate

70-05156 6 Hole Y-Shape

70-05188 8 Holed Curved, 1.0 mm Thick70-92018 10 Hole Curved, 0.5 mm Thick

70-92005 Strut Plate, 3 x 21 Holes, 0.5 mm Thick70-92008 Strut Plate, 3 x 21 Holes, 0.75 mm Thick



70-05356 49 Hole X-Plate

70-92013 Triangle Plate, 25 x 25 mm, 0.5 mm Thick70-92014 Triangle Plate, 30 x 30 mm, 0.5 mm Thick70-92015 Triangle Plate, 36 x 36 mm, 0.5 mm Thick

70-05145 Mesh, 55 x 55 x 0.5 mm 70-05345 Mesh, 55 x 55 x 0.75 mm

70-92016 Flexible Mesh, 55 x 55 x 0.5 mm70-92017 Flexible Mesh, 122 x 122 x 0.5 mm


1.7 mm plates and mesh are designed for cranial and frontal non-load bearing applications. The 1.7 mm plates, mesh, and instruments are color coded purple.

1.7

70-05355 Panel, 55 x 55 mm 70-92012 Panel, 122 x 122 x 0.75 mm

70-92001 Curved Strut Plate, 144 x 12 mm



70-06188 8 Hole Curved 70-06140 9 Hole L-Shape 110˚ R

70-06141 9 Hole L- Shape 110˚ L


2.2 mm plates and mesh are designed for mid-face non-load bearing applications. Note: 2.2 mm implants are not indicated for load bearing applications in the maxilla and mandible. The 2.2 mm plates, mesh, and instruments are color coded black.

2.2




70-06330 2 x 5 Hole Ladder

70-06365 8 Hole Strut Plate, 150 x 15 mm

70-06168 10 Hole Double-Y 70-06158 9 Hole Y-Shape


70-06355 55 x 55 x 1.4 mm Panel

70-06356 49 Hole X-Plate

70-92009 Strut Plate, 1 x 21 Holes, 1.4 mm Thick



Screwdriver Blades The Delta screwdriver blades have flanges at the sides for grasping the Delta screws.

• Positive engagement feedback.• Designed for increased retention.• Has greater blade/screw head contact and shorter shaft to minimize screw insertion instability.

Self-Drilling TapsSelf-drilling taps allow for drilling and tapping in a single step.

• Comes in various fixed lengths.• SD taps have dental and hex coupling options.

Quik Drive miniSelf-drilling taps allow for drilling and tapping in a single step.

• Comes in various fixed lengths.• SD taps have dental and hex coupling options.

Delta ScrewsScrew thread design provides excellent purchase and functional stability during insertion. Excellent fit between screw head and driver blade allows for easy pickup, insertion, and removal. Screw head sits flush within the plate, to ensure a true low profile plate and screw combination.

Torque-Limiting DriversTorque limiting driver's on/off switch allows for the option to increase or reduce torque for screw insertion or removal.

Delta Sterilization Container • Conveniently stores the modules, instrument trays, and the waterbath. • Contains all components required for the sterile field.

Delta Modules • Minimized sterile field presence.• Easy access to Delta instruments.

CMF Inventory Management Cart

• Designed specifically for CMF and Delta System inventory.• Provides greater storage capacity. • Flexible inventory management

for increased efficiency.• Adjustable in-drawer rows

and columns allow for custom organization of space for Delta sterile implant packs or other items.

Delta Waterbath

• Stores conveniently in the sterilization container.

• No sterile drape required.• Lightweight and fully autoclavable.

DeltaSystem Ordering InformationProduct # Description

1.7 mm Plates70-05114 Straight Plate, 14 Holes, 0.75 mm Thick70-05140 L Plate, 7 Holes, 110° Right, 0.75 mm Thick70-05141 L Plate, 7 Holes, 110° Left, 0.75 mm Thick70-05156 Y Plate, 6 Holes, 0.75 mm Thick70-05166 Double Y Plate, 6 Holes, 0.75 mm Thick70-05168 Double Y Plate, 8 Holes, 0.75 mm Thick70-05188 Curved Plate, 8 Holes, 0.75 mm Thick70-92018 Curved Plate, 10 Holes, 0.5 mm Thick70-05310 Box Plate, 2 x 2 Holes, 0.75 mm Thick70-05330 Ladder Plate, 2 x 5 Holes, 0.75 mm Thick70-05145 Mesh, 55 x 55 x 0.5 mm70-05345 Mesh, 55 x 55 x 0.75 mm70-05150 Mesh, 122 x 122 x 0.5 mm70-05350 Mesh, 122 x 122 x 0.75 mm70-92016 Flexible Mesh, 55 x 55 x 0.5 mm70-92017 Flexible Mesh, 122 x 122 x 0.5 mm70-05355 Panel, 55 x 55 x 1.0 mm70-05348 24 mm Burr Hole Cover, 0.75 mm Thick70-05356 X Plate, 49 Holes, 0.75 mm Thick70-92001 Curved Strut Plate, 144 x 12 mm70-05365 Strut Plate, 150 x 15 mm, 8 Holes70-92003 Strut Plate, 1 x 21 Holes, 0.5 mm Thick70-92004 Strut Plate, 2 x 21 Holes, 0.5 mm Thick70-92005 Strut Plate, 3 x 21 Holes, 0.5 mm Thick70-92006 Strut Plate, 1 x 21 Holes, 0.75 mm Thick70-92007 Strut Plate, 2 x 21 Holes, 0.75 mm Thick70-92008 Strut Plate, 3 x 21 Holes, 0.75 mm Thick70-92012 Panel, 122 x 122 x 0.75 mm70-92013 Triangle Plate, 25 x 25 mm, 0.5 mm Thick70-92014 Triangle Plate, 30 x 30 mm, 0.5 mm Thick70-92015 Triangle Plate, 36 x 36 mm, 0.5 mm Thick

1.7 mm Screws70-17203 1.7 x 3 mm, Pkg. 270-17204 1.7 x 4 mm, Pkg. 270-17205 1.7 x 5 mm, Pkg. 270-17206 1.7 x 6 mm, Pkg. 270-17403 1.7 x 3 mm, Pkg. 470-17404 1.7 x 4 mm, Pkg. 470-17405 1.7 x 5 mm, Pkg. 470-17406 1.7 x 6 mm, Pkg. 470-17104 1.7 x 4 mm, Pkg. 1070-17105 1.7 x 5 mm, Pkg. 10

2.2 mm Plates70-06104 Straight Plate, 4 Holes70-06108 Straight Plate, 8 Holes70-06114 Straight Plate, 14 Holes70-06121 Straight Plate, 21 Holes70-06140 L Plate, 9 Holes, 110° Right70-06141 L Plate, 9 Holes, 110° Left70-06158 Y Plate, 9 Holes70-06168 Double Y Plate, 10 Holes70-06188 Curved Plate, 8 Holes70-06330 Ladder Plate 2 x 5 Holes70-06345 Mesh, 55 x 55 x 1.0 mm70-06350 Mesh, 55 x 55 x 1.4 mm70-06355 Panel, 55 x 55 x 1.4 mm70-06356 X Plate, 49 Holes, 1.0 mm Thick70-06365 Strut Plate, 150 x 15 mm, 8 Holes70-92009 Strut Plate, 1 x 21 Holes, 1.4 mm Thick70-92010 Strut Plate, 2 x 21 Holes, 1.4 mm Thick70-92011 Strut Plate, 3 x 21 Holes, 1.4 mm Thick

2.6 mm Emergency Screw70-26006 2.6 x 6 mm, Pkg. 170-26008 2.6 x 8 mm, Pkg. 170-26010 2.6 x 10 mm, Pkg. 170-26204 2.6 x 4 mm, Pkg. 270-26206 2.6 x 6 mm, Pkg. 270-26208 2.6 x 8 mm, Pkg. 270-26210 2.6 x 10 mm, Pkg. 2

2.2 mm Screws70-22004 2.2 x 4 mm, Pkg. 170-22006 2.2 x 6 mm, Pkg. 170-22204 2.2 x 4 mm, Pkg. 270-22206 2.2 x 6 mm, Pkg. 270-22208 2.2 x 8 mm, Pkg. 270-22210 2.2 x 10 mm, Pkg. 270-22404 2.2 x 4 mm, Pkg. 470-22406 2.2 x 6 mm, Pkg. 470-22408 2.2 x 8 mm, Pkg. 470-22104 2.2 x 4 mm, Pkg. 1070-22106 2.2 x 6 mm, Pkg. 10

Countersinks70-71324 1.3 mm, 3 & 4 mm Screws, Stryker End70-71326 1.3 mm, 5 & 6 mm Screws, Stryker End70-71822 1.8 mm Countersink, Stryker End

Containers & Instrument Modules70-70002 Delta System Sterilization Container70-71702 1.7 mm Instruments Module70-72202 2.2 mm Instruments Module29-13022 Instrument Tray29-53000 CMF Inventory Management Cartt

Twist Drills70-71304 1.3 mm, 3 & 4 mm Screws, Stryker End70-71306 1.3 mm, 5 & 6 mm Screws, Stryker End70-71804 1.8 mm, 3 & 4 mm Screws, Stryker End70-71806 1.8 mm, 5 & 6 mm Screws, Stryker End70-71812 1.8 mm, 12 mm Length, Stryker End70-72204 2.2 mm, 4 mm Screws, Stryker End70-72206 2.2 mm, 6 mm Screws, Stryker End70-72212 2.2 mm, 12 mm Length, Stryker End

Bath System70-76001 Water Bath70-76005 Console 240V70-76003 Bath Sterilization Cord

Instruments70-71770 1.7 mm Screwdriver Blade70-76271 1.7 mm Screwdriver Handle70-71784 Self-Drilling Tap 1.7 mm, 3 & 4 mm, Dent70-71786 Self-Drilling Tap 1.7 mm, 5 & 6 mm, Dent70-71794 Self-Drilling Tap 1.7 mm, 3 & 4 mm, Hex70-71796 Self-Drilling Tap 1.7 mm, 5 & 6 mm, Hex70-71780 1.7 mm Bone Tap70-72270 2.2 mm Screwdriver Blade70-76273 2.2 mm Screwdriver Handle70-72284 Self-Drilling Tap 2.2 mm, 4 mm, Dent70-72286 Self-Drilling Tap 2.2 mm, 6 mm, Dent70-72288 Self-Drilling Tap 2.2 mm, 8 & 10 mm, Dent70-72294 Self-Drilling Tap 2.2 mm, 4 mm, Hex70-72296 Self-Drilling Tap 2.2 mm, 6 mm, Hex70-72298 Self-Drilling Tap 2.2 mm, 8 & 10 mm, Hex70-72280 2.2 mm Bone Tap70-72670 2.2/2.6 mm Screwdriver Blade70-76274 2.6 mm Screwdriver Handle70-72680 2.6 mm Bone Tap70-71817 Plate Forceps70-73736 Plate/Mesh Cutter70-76270 Tap Handle

Reconstructive

Hips

Knees

Trauma & Extremities

Joint Preservation

Orthobiologics

Medical & Surgical

Power Tools & Surgical Accessories

Image Guided Navigation

Endoscopy & Arthroscopy

Integrated Communications

Beds, Stretchers & EMS

Sustainability Solutions

Neurotechnology & Spine

Craniomaxillofacial

Interventional Spine

Neurosurgical, Spine & ENT

Neurovascular

Spinal ImplantsA surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery.

The information presented is intended to demonstrate the breadth of Stryker product offerings. A surgeon must always refer to the package insert, product label and/or instructions for use before using any Stryker product. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area.

Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: Delta, Stryker. All other trademarks are trademarks of their respective owners or holders.

References:

1. Habal, M.B.: Innovations in Plastic and Aesthetic Surgery, Chapter 21: The Utility of Biomaterials in Reconstructive Facial Plastic Surgery, 2008.2. Pietrzak, W.S. and Habal, M.B.: First Bioabsorbable Fixation System in Craniofacial Surgery on the 15th Anniversary of its US Utility, 2011.3. Ignatius, A.A. and Claes, L.E.: In vitro biocompatibility of Bioresorbable Polymers: poly (L. DL-lactide) and poly (L-lactide-co-glycolide), 1995.4. Ashammakhi, N., Gonzalez, A.M., Tormala, P., and Jackson, I.T.: New Resorbable Bone Fixation. Biomaterials in Craniomaxillofacial Surgery: Present and Future, 2003.5. Losken, H.W., Aalst, J.A., Mooney, M.P., Godfrey, V.L., Burt, T., Teotia, S., Dean, S.B., Moss, J.R., and Rahbar, R.: Biodegradation of Inion Fast-Absorbing Biodegradable Plates and Screws, 2008.6. Laughlin, R.M., Block, M.S., Wilk, R., Malloy, R.B., Kent, J.N.: Resorbable Plates for the Fixation of Mandibular Fractures: A Prospective Study, 2007.7. Posnick, J.C., and Ricalde, P.: Degradation Rate of Delta (Resorbable) Internal Fixation: Report of 2 Cases, 2004.8. Sasaki, C.T., Marotta, Ross, D.A., Johnson, M., and Lowlicht, R.A.: Efficacy of Resorbable Plates for Reduction and Stabilization of Laryngeal Fractures, 20039. Wittwer, G., Adeyemo, W.L., Yerit, K., Voracek, M., Turhani, D., Watzinger, F., and Enislidis, G.: Complications after Zygoma Fracture Fixation: Is there a difference between Biodegradable Materials and How do they compare with Titanium Osteosynthesis?, 2006.

Literature Number: 9410-400-305-SSP Rev. AUnDe/P.S.

Copyright © 2014 StrykerPrinted in Australia

Stryker South Pacific8 Herbert StreetSt LeonardsNSW 2065 AustraliaPh: +61 2 9467 1000Fax: +61 2 9467 1010 Stryker New Zealand515 Mt. Wellington HighwayAuckland 1060 New ZealandPh: +64 9 573 1890Fax: +64 9 573 1891

www.stryker.com

Documents

Delta System - Stryker MedEd resorbable plates/screws are implanted into patients, their bodies breakdown and remove the polymers through ... 1.7 mm Delta Plates 1.7 mm Resorbable