` VERTE-STACK™ PEEK Vertebral Body Spacer
`
`1
`
`NUVASIVE 2012
`Medtronic v. NuVasive
`IPR2013-00506
`IPR2013-00507
`IPR2013-00508
`
`
`
`BOOMERANG™
`Design Features
`
`– PEEK material
`– 25mm, 30mm and 36mm width
`– 6mm to 18mm heights
`– Anatomical shaped
`(convex surfaces in both saggital
`and coronal plane)
`– 7° lordosis
`– Radiographic markers
`– Large surface area to reduce subsidence
`– Large area for bone graft
`– Multiple Inserter attachment options
`
`25mm
`
`30mm
`
`AP Depth
`11mm
`
`AP Depth
`13mm
`
`25mm Width
`6-15mm Heights
`
`30mm Width
`7-18mm Heights
`
`36mm
`
`AP Depth
`13mm
`
`36mm Width
`7-18mm Heights
`
`Alignment Rod 2
`
`Trial
`Inserter
`
`Implant
`Inserter
`
`Pusher
`
`Screwdriver
`
`Alignment Rod 1
`
`2
`
`
`
`STEP 1 Attach the appropriate sized BOOMERANG™
`Implant to the Inserter by placing the Implant
`into the “Claw” on the Inserter and tighten with
`the Screwdriver.
`
`STEP 2 Use the Inserter, in combination with the Pusher, to
`begin insertion of the BOOMERANG™ Implant
`into the vertebral body.
`
`STEP 3 Rotate the Inserter Handle to the “second position” and impact BOOMERANG™ Implant across the vertebral body.
`
`3
`
`
`
`BOOMERANG™ Alignment Rod #2
`
`BOOMERANG™ Alignment Rod #1
`
`STEP 4 Use the Alignment Rods to verify the final position of the BOOMERANG™ Implant. Once final position has been
`verified, remove the Inserter using the Screwdriver.
`
`NOTE: Step 2 and Step 3 may be reversed based on patient anatomy.
`
`4
`
`
`
`PEEK Material Advantages
`
`Radiolucency
`
` • Easier visualization of bone growth
` • No scatter or artifact with CTs and MRIs
`
`Biocompatibility
` • Long history of usage
` – Dental Implants
` – Heart Valves/Stents
` – Artificial Joints
` – Finger Implants
` – Spinal Implants
`
`Strength
` • Offers greater impact resistance
` • High ultimate strength
` • High fatigue strength
`
`Wear Resistance
` • ZERO wear debris was generated during
`fatigue testing
`
`Modulus of Elasticity
` • MOE between cancellous and cortical bone
` • Ideal load sharing implant
`
`Ultimate Strength
`
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`5
`
`
`
`For product availability, labeling limitations, and/or more information on any Medtronic Sofamor Danek products,
`contact your MEDTRONIC SOFAMOR DANEK USA, INC. Sales Associate,
`or call MEDTRONIC SOFAMOR DANEK USA, INC. Customer Service toll free: 800-933-2635.
`
`MEDTRONIC SOFAMOR DANEK USA, INC.
`1800 Pyramid Place Memphis, TN 38132
`(901) 396-3133 (800) 876-3133
`Customer Service: (800) 933-2635
`
`www.sofamordanek.com
`
`The BOOMERANG™ VERTE-STACK™ PEEK Vertebral Body Spacer is a vertebral body replacement device intended for use in the
`thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The
`BOOMERANG™ device is to be used with supplemental fixation. Specifically, the BOOMERANG™ device is to be used with the Medtronic
`Sofamor Danek ZPLATE II™ Anterior Fixation System, Titanium DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation
`System, Titanium TSRH® Spinal System, Titanium CD HORIZON® Spinal System, the Titanium GDLH® Spinal System, or their successors.
`Additionally, the BOOMERANG™ device is intended to be used with bone graft.
`
`©2003 Medtronic Sofamor Danek USA, Inc. All Rights Reserved. Patents Pending.
`
`MLITBOOMBR3
`
`6
`
`
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