VBOSS TM System Overview. Vertebral Body Support System

VBOSS TM System Overview Vertebral Body Support System

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

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

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. 1. 1 small end cap 0 + 1 small end cap 0 2. 1 small end cap 0 + 1 large end cap 0 3. 1 large end cap 0 + 1 large end cap 0 4. 1 small end cap 0 + 1 small end cap 5 5. 1 small end cap 5 + 1 large end cap 0 6. 1 small end cap 0 + 1 large end cap 5 7. 1 small end cap 5 + 1 small end cap 5 8. 1 small end cap 5 + 1 large end cap 5 9. 1 large end cap 0 + 1 large end cap 5 10. 1 large end cap 5 + 1 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

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

Implants Cages: Diameter (ØExternal) [mm] Height (mm) Ø10* Ø12 Ø14 Ø16 Ø20 Ø25 8 336612008 336614008 9 336612009 336614009 10 336612010 336614010 11 336612011 336614011 12 336612012 336614012 40 336612040 336614040 336616040 336620040 336625040 60 336610060 80 336612080 336614080 336616080 336620080 336625080 120 336620120 336625120 *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 33661000SR 33661200SR 33661400SR 33661600SR 33662000SR 33662500SR Large 33661000MR 33661200MR 33661400MR 33661600MR 33662000MR 33662500MR 5 Small 33661005SR 33661205SR 33661405SR 33661605SR 33662005SR 33662505SR Large 33661005MR 33661205MR 33661405MR 33661605MR 33662005MR 33662505MR Oval 0 Small 33662000SO 33662500SO Large 33662000MO 33662500MO 5 Small 33662005SO 33662505SO Large 33662005MO 33662505MO 10 Small 33662010SO 33662510SO Large 33662010MO 33662510MO *Ø10mm cage not for sale in the U.S. 6

Instruments Instruments Quanty Per Set Cat. No. Description Standard Configuration 33660300 Parallel Distractor 1 33660310 End Plate Tip small (pair) 1 33660320 End Plate Tip medium (pair) 1 33660330 End Plate Tip large (pair) 1 33660340 End Plate Tip Finger (pair) 1 33660350 End Plate Tip Offset (pair) 1 33660100 Cage Cutter 1 33660111 Cutting Blade Shaft 5 33660112 Cutting Blade 5 33660210 Mandrel Ø10mm* 1 33660212 Mandrel Ø12mm 1 33660214 Mandrel Ø14mm 1 33660216 Mandrel Ø16mm 1 33660220 Mandrel Ø20mm 1 33660225 Mandrel Ø25mm 1 33660410 Pin Ø10mm* 0# 33660412 Pin Ø12mm 0# 33660414 Pin Ø14mm 0# 33660416 Pin Ø16mm 0# 33660420 Pin Ø20mm 0# 33660425 Pin Ø25mm 0# 33660500 Standard Cage Inserter 1 33660250 Cage Deburring Tool 1 33660700 Small Cage Inserter 1 33660050 Caliper 1 33660650 Base End Cap Impactors 1 33660652 End Cap Impactor Angle 5 1 33660450 Small Graft Impactor 1 33660460 Graft Impactor 1 33660600 Cage Impactor 1 33660800 Ratcheting Handle 1 33660850 End Cap Remover 1 33660002 Implant Box USA 1 33660003 Instrument Box USA 1 33660860 International Version Radiographic Template 1 33660870 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

2 Pearl Court Allendale, NJ 07401 t: 877-946-9678 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 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