Reflex Hybrid System Overview

Transcription

1 Spine Reflex Hybrid System Overview Anterior Cervical Plating System

2 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.

3 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

4 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

5 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.

6 Implants Part # Description Screw Color Part # Description Plate Variable Angle Bone Screws, Self-Tapping x 10mm x 12mm x 14mm x 16mm x 18mm x 20mm x 12mm x 14mm x 16mm x 18mm x 20mm Variable Angle Bone Screws, Self-Drilling x 10mm x 12mm x 14mm x 16mm x 18mm Fixed Angle Bone Screws, Self-Tapping x 10mm x 12mm x 14mm x 16mm x 18mm x 20mm x 12mm x 14mm x 16mm x 18mm x 20mm Fixed Angle Bone Screws, Self-Drilling x 10mm x 12mm x 14mm x 16mm x 18mm One-Level Anterior Cervical Plate Size 12mm Size 14mm Size 16mm Size 18mm Size 20mm Size 22mm Two-Level Anterior Cervical Plate Size 24mm Size 26mm Size 28mm Size 30mm Size 32mm Size 34mm Size 37mm Size 40mm Size 43mm Size 46mm Three-Level Anterior Cervical Plate Size 39mm Size 42mm Size 45mm Size 48mm Size 51mm Size 54mm Size 57mm Size 60mm Size 63mm Size 66mm Size 69mm Four-Level Anterior Cervical Plate Size 60mm Size 64mm Size 68mm Size 72mm Size 76mm Size 80mm Size 84mm

7 Instruments Part # Description Part # Description Container - Implants Quick-Release Handle Container - Instruments Caliper Plate Bender Drill - 10 mm Drill - 12 mm Drill - 14 mm Drill - 16 mm Drill - 18 mm Drill - 20 mm Plate Holder Awl Fixation Pin Inserter Tap Temporary Fixation Pin, Standard Screwdriver Temporary Fixation Pin, Long Final-Tightening Screwdriver Single-Barrel Drill- Guide - Fixed Single-Barrel Drill- Guide - Variable Rescue Screwdriver w/ Inside Shaft Revision Screwdriver Double-Barrel Drill-Guide - Fixed Double-Barrel Drill-Guide - Variable All-in-one Guide - Fixed* All-in-one Guide - Variable* *Release date to be announced.

8 EU Operations Z.I. Marticot Cestas - FRANCE Phone: +33(0) Phone: +33(0) US Operations 325 Corporate Drive Mahwah, New Jersey USA Phone: Fax: US Patent Number 6,261,291 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