`
`VERTE-STACK™ PEEK Vertebral Body Spacer
`
`For product availability, labeling limitations, and/or more information on any MEDTRONIC SOFAMOR DANEK USA, INC.
`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 VERTE-STACK™ TELAMON™ 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 VERTE-STACK™ TELAMON™ device is to be used with supplemental
`fixation. Specifically, the VERTE-STACK™ TELAMON™ 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 VERTE-STACK™ TELAMON™ device is intended to be used with bone graft.
`
`©2003 Medtronic Sofamor Danek USA, Inc. All Rights Reserved. Patents Pending.
`
`LITTEPBR3
`
`Distributed by Medtronic Sofamor Danek USA, Inc., Memphis, TN
`
`MSD 1107
`
`1
`
`
`
`Static Limits
`
`20000
`
`14,100
`
`10,000
`
`10000
`
`Load (N)
`
`TELAMON™ Design Features
`
`– PEEK material
`– Consistent 10mm width
`– 8mm to 14mm heights
`– Anatomical shape
`– 3° lordosis
`– Tantalum Radiographic markers
`– Large surface area to reduce subsidence
`– Large area for bone graft
`
`TELAMON™
`PEEK
`Device
`
`CarbonFiber
`Reinforced
`PEEK
`(CFRP)
`Device
`Vertebral endplates break at 10,000 N
`
`Fatigue Limits
`
`8,000
`
`2,000
`
`CarbonFiber
`Reinforced
`PEEK
`(CFRP)
`Device
`
`TELAMON™
`PEEK
`Device
`
`10000
`
`5000
`
`Load (N)
`
`C
`
`A
`
`B
`
`C
`
`A
`
`B
`
`22mm
`
`26mm
`
`Implant Designator
`
`Dimension
`
`8mm
`22mm
`
`10mm
`22mm
`
`12mm
`22mm
`
`14mm
`22mm
`
`8mm
`26mm
`
`10mm
`26mm
`
`12mm
`26mm
`
`14mm
`26mm
`
`A
`
`B
`
`C
`
`8mm 10mm 12mm 14mm 8mm 10mm 12mm 14mm
`
`10.2mm 12.2mm 14.2mm 16.2mm 10.6mm 12.6mm 14.6mm 16.6mm
`
`3 deg
`
`3 deg
`
`3 deg
`
`3 deg
`
`3 deg
`
`3 deg
`
`3 deg
`
`3 deg
`
`PEEK Material Advantages
`
`Radiolucency
` • Easier visualization of bone growth
` • Minimal 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
` • Minimal wear debris was generated
`during fatigue testing
`
`Modulus of Elasticity
` • Elastic (Young’s) Modulus between
`cancellous and cortical bone
` • Ideal load sharing implant
`
`Modulus of Elasticity (MOE)
`Modulus of Elasticity is a measure of a material’s stiffness.
`The higher the Modulus of Elasticity, the stiffer the material.
`The lower the Modulus of Elasticity the better the load
`sharing.
`PEEK
`• 50% less stiff than CFRP
`• More closely approximates the MOE of cancellous bone,
` making it a better load sharing device.
`Modulus of Elasticity
`
`50% Less
`
`8.8
`
`3.7
`
`Cancellous
`Cancellous
`Bone
`Bone
`
`PEEK
`PEEK™
`Material
`Material
`
`CarbonFiber
`Carbon Fiber
`Reinforced
`Reinforced
`PEEK
`PEEK™
`(CFRP)
`
`Cortical
`Cortical
`Bone
`Bone
`
`20
`20
`
`15
`15
`
`10
`10
`
`5
`5
`
`0
`0
`
`Stiffness
`Stiffness
`
`2
`
`