medtronic

12 Deg Lordotic, Rasp, Large, 16mm

Endoskeleton TA Interbody Fusion Device Important Infomation

96 Pages

Endoskeleton™ TA Interbody Fusion Device  M333023W098EU Rev. A  STAND WITH THE FUTURE™ 2020-07-21  ENGLISH  IMPORTANT INFORMATION ON THE ENDOSKELETON™ TA INTERBODY FUSION DEVICE  Note: not all parts may be available in each geography.  DESCRIPTION Endoskeleton™ TA Interbody Fusion Device implants are designed with a large hollow region in the center to house autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof. The new bone formation through the implant is intended to provide long-term structural support and fusion at the implanted disc space. The design incorporates “windows” through the implant to permit visualization of the graft material and over time formation of new bone. Devices incorporate Titan Surface Technologies™, where superior and inferior surfaces include either the Chemtex™ surface treatment or nanoLOCK™ surface treatment (MMN™) designed to improve fixation to the adjacent bone. The nanoLOCK™ surface technology (MMN™) provides a microscopic roughened surface with nano-scale features. Implants are composed of ASTM F136 Ti 6Al-4V ELI titanium alloy and provided either sterile or non-sterile. An implant holding feature is incorporated into the trailing surface of the implant to mate with the implant holder, and to facilitate placement of the implant into the interbody space. The Endoskeleton™ TA Interbody Fusion Device should only be implanted by surgeons experienced in the use of such implants and the required specialized spinal surgery techniques.  INDICATIONS The Endoskeleton™ TA Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device is to be used with supplemental fixation cleared by the FDA for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Endoskeleton™ TA Interbody Fusion Device is indicated to be used with autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof.  WARNINGS When using metallic implants, be aware of the following: ▪ Correct selection of the implant is extremely important. Potential for success is increased by selection of proper size, shape, and design of the implant. ▪ Correct handling of implants is extremely important. Contouring of implants is to be avoided. Endoskeleton™ TA Interbody Fusion Device implants were designed for single patient use only. Do not reprocess or reuse this product. Reuse or reprocessing may compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death.  CONTRAINDICATIONS ▪ The Endoskeleton™ TA Interbody Fusion Device should never be implanted in patients with a systemic or local infection.  ▪ The Endoskeleton™ TA Interbody Fusion Device should not be used with components of any other interbody systems. Supplemental fixation cleared by the FDA for use in the lumbar spine must be used.  ▪ The Endoskeleton™ TA Interbody Fusion Device should not be implanted in patients with an allergy to titanium or titanium alloys.  ▪ All patients should have at least 6 months of non-operative care prior to spinal fusion with the Endoskeleton™ TA Interbody Fusion Device.  ▪ The Endoskeleton™ TA Interbody Fusion Device should not be implanted in patients with a prior fusion at the level(s) to be treated.
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