Reflex Hybrid System Overview

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Spine Reflex Hybrid System Overview Anterior Cervical Plating System

Introduction The Reflex Hybrid ACP System offers a low-profile anterior cervical plate along with a selection of bone screw types to allow for a wide variety of constructs. Depending on the component combination, the system can accommodate both rigid and semi-constrained bone screw fixation philosophies. Instrument options further enhance surgical technique versatility by matching surgeon preference regarding approach and screw pathway preparation. Construct Types Constrained Insertion of fixed angle screws into all levels of the Reflex Hybrid plate provides a rigid fixation for cases, in which a constrained construct is desired. Semi-constrained Insertion of variable angle screws into all levels of the Reflex Hybrid plate results in a semi-constrained construct, which allows settling under loading conditions. Hybrid Insertion of fixed screws at one level and variable screws at remaining levels provides a hybrid option that combines stability and a limited amount of construct settling.

Implants Low-profile plate The Reflex Hybrid plate, made from a Ti-6Al-4V alloy, features a constant thickness of 1.95mm to help reduce soft tissue irritation and to provide a suitable option for small stature patients. The radius of curvature is 160mm in the sagittal plane and 30mm in the axial plane for optimal matching of the patient s anatomy. Locking ring The one-step locking ring of the Reflex Hybrid system, which is integrated into every screw hole, expands upon screw insertion and then contracts over the head to hold each screw securely in place. Anodization (gold color) facilitates visual confirmation of the ring being clearly locked over the bone screw head. Graft windows The large graft-viewing windows allow for visualization of the endplates to aid in graft and implant positioning. Screw options The Reflex Hybrid ACP system offers fixed and variable angle screws to accommodate a variety of constructs. Both fixed and variable screws are offered as self-tapping, which feature a cutting flute and a less aggressive screw tip, and self-drilling, which have been designed with a sharp tip for insertion without prior drilling. Screw Type Variable Angle Fixed Angle 4.0mm Self-Tapping 4.0mm Self-Drilling 4.5mm Self-Tapping

Screw Angulation The neutral axis of the screw holes is defined as follows: End holes: 8 cephalad or 8 caudal in the sagittal plane from perpendicular to the plate curvature Middle holes: 0 degrees (perpendicular to the plate) All types of screws have 8 of medial convergence in the axial plane. 8º 8º 8º 0º 8º Fixed bone screws used in end holes are inserted into the plate in the neutral position described above, and they remain in this position under loading. Fixed bone screws in the middle holes are also inserted along the neutral axis, perpendicularly to the plate. 8º 0º 8º Variable angle bone screws allow sagittal angulation of the screw within a certain range (+/- 6 degrees) measured from the neutral axis. For bone screws inserted into end holes, the resulting range of angulation is 2 to 14 degrees, while the middle-hole screw holes allow for +/- 6 degrees of angulation. +/- 6º +/- 6º +/- 6º 14º 2º

Instruments Fixed vs. variable Both the fixed and the variable angle guide instruments direct the screw trajectory within the range that ensures optimal functioning of the locking ring. While certain instruments such as the awl, drills, tap, and all the screwdrivers are used for all types of bone screws, the drill guides must correspond to whether fixed or variable angle bone screws will be implanted. The variable angle guides can be identified by their blue handle, while the fixed angle guides are purple. All-in-one guide* The all-in-one guide provides a secure cannula for drilling, tapping (if desired), and screw insertion. As an alternative to drilling, awl can also be used through the guide for screw pathway preparation. The main advantage of the all-in-one guide is the consistent angulation of all instruments once the guide is attached to the plate. The guide also serves as a tissue protector and a portal for screw insertion, which minimizes the amount of exposure and retraction necessary at the surgery site. *Release date to be announced.

Implants Part # Description Screw Color Part # Description Plate Variable Angle Bone Screws, Self-Tapping 48684010 4.0 x 10mm 48684012 4.0 x 12mm 48684014 4.0 x 14mm 48684016 4.0 x 16mm 48684018 4.0 x 18mm 48684020 4.0 x 20mm 48684512 4.5 x 12mm 48684514 4.5 x 14mm 48684516 4.5 x 16mm 48684518 4.5 x 18mm 48684520 4.5 x 20mm Variable Angle Bone Screws, Self-Drilling 48664010 4.0 x 10mm 48664012 4.0 x 12mm 48664014 4.0 x 14mm 48664016 4.0 x 16mm 48664018 4.0 x 18mm Fixed Angle Bone Screws, Self-Tapping 48674010 4.0 x 10mm 48674012 4.0 x 12mm 48674014 4.0 x 14mm 48674016 4.0 x 16mm 48674018 4.0 x 18mm 48674020 4.0 x 20mm 48674512 4.5 x 12mm 48674514 4.5 x 14mm 48674516 4.5 x 16mm 48674518 4.5 x 18mm 48674520 4.5 x 20mm Fixed Angle Bone Screws, Self-Drilling 48654010 4.0 x 10mm 48654012 4.0 x 12mm 48654014 4.0 x 14mm 48654016 4.0 x 16mm 48654018 4.0 x 18mm One-Level Anterior Cervical Plate 48650112 Size 12mm 48650114 Size 14mm 48650116 Size 16mm 48650118 Size 18mm 48650120 Size 20mm 48650122 Size 22mm Two-Level Anterior Cervical Plate 48650224 Size 24mm 48650226 Size 26mm 48650228 Size 28mm 48650230 Size 30mm 48650232 Size 32mm 48650234 Size 34mm 48650237 Size 37mm 48650240 Size 40mm 48650243 Size 43mm 48650246 Size 46mm Three-Level Anterior Cervical Plate 48650339 Size 39mm 48650342 Size 42mm 48650345 Size 45mm 48650348 Size 48mm 48650351 Size 51mm 48650354 Size 54mm 48650357 Size 57mm 48650360 Size 60mm 48650363 Size 63mm 48650366 Size 66mm 48650369 Size 69mm Four-Level Anterior Cervical Plate 48650460 Size 60mm 48650464 Size 64mm 48650468 Size 68mm 48650472 Size 72mm 48650476 Size 76mm 48650480 Size 80mm 48650484 Size 84mm

Instruments Part # Description Part # Description 48510000 Container - Implants 48510600 Quick-Release Handle 48510001 Container - Instruments 48510100 Caliper 48510200 Plate Bender 48510610 Drill - 10 mm 48510612 Drill - 12 mm 48510614 Drill - 14 mm 48510616 Drill - 16 mm 48510618 Drill - 18 mm 48510620 Drill - 20 mm 48510300 Plate Holder 48510650 Awl 48510400 Fixation Pin Inserter 48510700 Tap 48510410 Temporary Fixation Pin, Standard 48510800 Screwdriver 48510420 Temporary Fixation Pin, Long 48510810 Final-Tightening Screwdriver 48510500 Single-Barrel Drill- Guide - Fixed 48510505 Single-Barrel Drill- Guide - Variable 48510900 Rescue Screwdriver w/ Inside Shaft 48510910 Revision Screwdriver 48510510 Double-Barrel Drill-Guide - Fixed 48510515 Double-Barrel Drill-Guide - Variable 48510520 All-in-one Guide - Fixed* 48510525 All-in-one Guide - Variable* *Release date to be announced.

EU Operations Z.I. Marticot 33610 Cestas - FRANCE Phone: +33(0)5 57 97 06 30 Phone: +33(0)5 57 97 06 31 US Operations 325 Corporate Drive Mahwah, New Jersey 07430 - USA Phone: +1 201 831 5000 Fax: + 1 201 760 8108 US Patent Number 6,261,291 www.stryker.com The information presented in this brochure is intended to demonstrate the breadth of Stryker product offerings. Always refer to the package insert, product label and/or user instructions before using any Stryker product. Surgeons must rely on their own clinical judgement when deciding which product and treatments to use with their patients. Products may not be available in all markets. Product availability is subject to the regulatory or medical practices that govern individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area. Products referenced with TM designation are trademarks of Stryker. Products referenced with designation are registered trademarks of Stryker. Literature Number: LSRHOB GC/GS 1m 09/04 Copyright 2004 Stryker Printed in USA