VBOSS TM System Overview. Vertebral Body Support System

Transcription

1 VBOSS TM System Overview Vertebral Body Support System

2 Introduction The Vertebral Body Support System (VBOSS TM ) provides structural anterior column support using precisely fit titanium implants. Each implant is created through quick, efficient cutting with modular end caps that perfectly match patient anatomy to restore normal spinal alignment. The VBOSS TM System is intended to replace a vertebral body or an entire vertebra in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body or vertebra due to tumor or trauma (e.g. fracture). For both corpectomy and vertebrectomy procedures, VBOSS TM is intended to be used with supplemental internal spine fixation systems. The supplemental internal fixation systems that may be used with VBOSS include, but are not limited to, Stryker Spine plate or rod systems (Xia Spinal System, Spiral Radius 90D and Trio TM ). The use of bone graft is optional. Case Report: The x-rays show a 3 month follow up AP view of a 27 year old male who fell two stories at a construction site sustaining an unstable L1 burst fracture with lower extremity paraparesis. Initial films showed a L1 burst fracture with marked comminution, severe spinal canal compromise and 20 degrees of kyphosis. The patient was treated with the VBOSS TM System with supplemental anterior fixation using XIA Anterior. The patient went on to make a near complete neurologic recovery. Pre-operative and 3 month follow-up x-rays of a patient presenting a burst fracture and treated with a Ø20mm x 40mm VBOSS TM implant construct. 2

3 Product Features The VBOSS TM System was designed to provide complete modularity using multiple combinations of cages and end caps. The versatility of the VBOSS TM sizing options allows the surgeon to optimally match the implant to the vertebral defect. A custom fit more readily maintains lordosis and restored height. Cages Cages are available in six diameters from Ø10mm* to Ø25mm and nine heights from 8mm to 120mm (see page 6). Each cage contains grooves, located 5mm apart, which are designed to aid in cutting. The sides of each cage are perforated by equally spaced holes to allow optimal porosity to maximize bony fusion. *Ø10mm cage not for sale in the U.S. Ø10* Ø12 Ø14 Ø16 Ø20 Ø25 Implants are color-coded for easy size identification 5mm 3

4 Product Features End Caps Modular end caps snap into each end of the cage. The exterior side of the end cap features evenly spaced spikes providing fixation to the bony end plate. End Caps 10 The end caps are available in six diameters, two shapes, and three lordotic angles, resulting in 10 possible unique end cap configurations (see page 6). 5 Two shapes: round and oval. If increased surface area is desired, oval end caps should be used. The oval end caps maximize the implant footprint on the vertebral end plate for greater load bearing, load sharing and stability. 3.3mm 0 Round 10 Three lordotic angles: 0, 5 and 10 Two heights: small (1.65mm) and large (3.3mm) 5 Both the cages and end caps are colorcoded for easy diameter identification. 1.65mm Oval 0 Versatility When using the small cage heights, which range in diameter from Ø10mm* to Ø14mm and 8mm to 12mm in height, the VBOSS TM System allows for millimetric adjustments. Furthermore, the surgeon can build 10 different construct configurations when using the end caps, example: Ø12mm x 8mm construct: *Ø10mm cage not for sale in the U.S small end cap small end cap small end cap large end cap large end cap large end cap small end cap small end cap small end cap large end cap small end cap large end cap small end cap small end cap small end cap large end cap large end cap large end cap large end cap large end cap 5 Larger cage constructs, available in diameters Ø16mm, Ø20mm and Ø25mm, can be cut in 5mm increments in the cage grooves. The implant can then be customized from 1.65mm to 3.3mm height increments using the end caps. For example: A Ø20mm x 40mm construct can be cut to 30mm in length and sized accordingly: 30mm + 2 small end caps = 33.3mm 30mm + 1 small end cap + 1 large end cap = 34.95mm 30mm + 2 large end caps = 36.6mm Implant Material The cages and end caps are made of commercially pure titanium (T60). Titanium is easy to cut, yet strong enough not to deform under compression. Titanium is also biocompatible, x-ray visible, MRI compatible, load bearing and structural. 4

5 Product Features Cage Cutter The cage cutter guarantees a clean cut. The angulation between the blade and the cage is at a 90 angle to optimize the cutting surface. A base plate and silicon feet provide stability for the cage cutter. The blade, guided by its supporting frame, cuts within the grooves of each implant. Unique Insertion & Distraction Instrumentation Parallel distractor: The two-in-one distractor provides simultaneous distraction while serving as an insertion guide for the implant construct. Its appropriate use enables cage insertion without scraping or damaging the end plates. The end tips can be attached on either side for both left and right hand use of the distractor. Cage inserters: The standard and small inserters were designed not to exceed the profile of the cage construct. The small inserter is only 8mm wide and is truly low profile. 5

6 Implants Cages: Diameter (ØExternal) [mm] Height (mm) Ø10* Ø12 Ø14 Ø16 Ø20 Ø *Ø10mm cage not for sale in the U.S. End Caps: Diameter (ØExternal) [mm] Shape Angle Height Ø10* Ø12 Ø14 Ø16 Ø20 Ø25 Round 0 Small SR SR SR SR SR SR Large MR MR MR MR MR MR 5 Small SR SR SR SR SR SR Large MR MR MR MR MR MR Oval 0 Small SO SO Large MO MO 5 Small SO SO Large MO MO 10 Small SO SO Large MO MO *Ø10mm cage not for sale in the U.S. 6

7 Instruments Instruments Quanty Per Set Cat. No. Description Standard Configuration Parallel Distractor End Plate Tip small (pair) End Plate Tip medium (pair) End Plate Tip large (pair) End Plate Tip Finger (pair) End Plate Tip Offset (pair) Cage Cutter Cutting Blade Shaft Cutting Blade Mandrel Ø10mm* Mandrel Ø12mm Mandrel Ø14mm Mandrel Ø16mm Mandrel Ø20mm Mandrel Ø25mm Pin Ø10mm* 0# Pin Ø12mm 0# Pin Ø14mm 0# Pin Ø16mm 0# Pin Ø20mm 0# Pin Ø25mm 0# Standard Cage Inserter Cage Deburring Tool Small Cage Inserter Caliper Base End Cap Impactors End Cap Impactor Angle Small Graft Impactor Graft Impactor Cage Impactor Ratcheting Handle End Cap Remover Implant Box USA Instrument Box USA International Version Radiographic Template U.S. Version Radiographic Template 1 NOTE: # Can be ordered if replacement needed. Original pins are already fitted on the mandrels. *not for sale in the U.S. 7

8 2 Pearl Court Allendale, NJ t: 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 always rely on their own clinical judgment when deciding which treatments and procedures to use with 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. The marks bearing the symbol are trademarks of Stryker. The marks bearing the symbol are registered trademarks of Stryker. Literature Number: IBDVBOSSBR01 GC/GS 7C 08/05 Copyright 2005 Stryker Printed in USA