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The Endoskeleton TT Interbody Fusion Device implants are available in a curved shape and 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. The 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. The implants are composed of ASTM F136 Ti 6Al-4V ELI titanium alloy and are provided either sterile or non-sterile.
An implant holding feature has been 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 TT 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 must be used with supplemental fixation that has been 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). It is indicated to be used with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate.
In using metallic implants, the surgeon should be aware of the following:
Preoperative:
Intraoperative:
Postoperative:
Possible adverse effects include, but are not limited to, bending, loosening, or fracture of the implants or instruments; loss of fixation; sensitivity to a metallic foreign body, including possible tumor formation; skin or muscle sensitivity in patients with inadequate tissue coverage over the operative site, which may result in skin breakdown and/or wound complications; nonunion or delayed union; infection; nerve or vascular damage due to surgical trauma, including loss of neurological function, dural tears, radiculopathy, paralysis, and cerebral fluid leakage; gastrointestinal, urological and/or reproductive system compromise, including sterility, impotency, and/or loss of consortium; pain or discomfort; bone loss due to resorption or stress shielding, or bone fracture at, above, or below the level of surgery (fracture of the vertebra); hemorrhage of blood vessels and/or hematomas; malalignment of anatomical structures, including loss of proper spine curvature, correction, reduction, and/or height; bursitis; bone graft donor site pain; inability to resume activities of normal daily living; reoperation or death.
The Endoskeleton TO Interbody Fusion Device implants are available in a variety of sizes for treatment in Posterior Lumbar Interbody Fusion (PLIF) used in pairs oriented longitudinally from posterior to anterior and a 31 mm length for use in angled or Oblique single placement treatment across the disc space, and 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. The 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. The implants are composed of ASTM F136 or ASTM F3001 Ti 6Al-4V ELI titanium alloy and are provided either sterile or non-sterile.
An implant holding feature has been 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 TO 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 backpain 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 must be used with supplemental fixation that has been 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). The device is indicated to be used with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate.
In using metallic implants, the surgeon should be aware of the following:
Preoperative:
Intraoperative:
Postoperative:
Possible adverse effects include, but are not limited to, bending, loosening, or fracture of the implants or instruments; loss of fixation; sensitivity to a metallic foreign body, including possible tumor formation; skin or muscle sensitivity in patients with inadequate tissue coverage over the operative site, which may result in skin breakdown and/or wound complications; nonunion or delayed union; infection; nerve or vascular damage due to surgical trauma, including loss of neurological function, dural tears, radiculopathy, paralysis, and cerebral fluid leakage; gastrointestinal, urological and/or reproductive system compromise, including sterility, impotency, and/or loss of consortium; pain or discomfort; bone loss due to resorption or stress shielding, or bone fracture at, above, or below the level of surgery (fracture of the vertebra); hemorrhage of blood vessels and/or hematomas; malalignment of anatomical structures, including loss of proper spine curvature, correction, reduction, and/or height; bursitis; bone graft donor site pain; inability to resume activities of normal daily living; reoperation or death.