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The TM-400 device 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 TM-400 device is intended for use with supplemental internal fixation systems, and may be used with autograft or allograft. The TM-400 device is also intended for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. The TM-400 device is intended for use with supplemental internal fixation and autogenous bone graft.

The TM-400 Device is an oval shaped ALIF device for interbody fusion of the anterior column of the spine. The TM-400 Device is currently cleared to accommodate the replacement of a vertebral body in the thoracic and lumbar region of the spine. Use of this device is expanded to include use as an interbody fusion device. TM-400 Device is designed for fusing the adjacent bony surfaces and may be used to replace a disc at one or two contiguous levels in L2-S1. The device is available in a variety of cross sections and heights to accommodate variations in the individual pathology and anatomic condition of the patient. TM-400 implants are also available in two lordotic angles 7 degree and 13 degree. The superior and inferior surfaces of the device contain a pattern of teeth to provide for initial stability. The device also has slots to mate with the insertion instrument. The TM-400 device is wholly comprised of Trabecular Metal Porous Tantalum. Surgical instrumentation for use with the proposed system are fabricated from surgical grade stainless steel and other applicable materials.

Trabecular Metal Femoral Cone Augments are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution - Rotating Hinge Knee (RHK) System, the Trabecular Metal Femoral Cone Augments are for cemented use only. When used with the NexGen Complete Knee Solution - Legacy Constrained Condylar Knee System, the Trabecular Metal Femoral Cone Augments are for cementless or cemented use.

The NexGen® Trabecular Metal™ Femoral Cone Augments are manufactured wholly of Trabecular Metal™, porous tantalum. The existing, commercially available NexGen® Trabecular Metal™ Femoral Cone Augments have a tapered elliptical cross-section. The periphery of the distal end is larger than that of the proximal end. The cone is not fully enclosed at its top most proximal section (giving the impression of U-Shape through slot). A similar pattern is also present in the modified femoral cones, with the exception that these cones are fully enclosed at its top most proximal section. Both the modified femoral cones augments and the existing, commercially available femoral cone augments are to be used in conjunction with Zimmer's NexGen® Complete Knee Systems -both the Legacy® Constrained Condylar Knee (LCCK) Stemmed Femoral Implant and the femoral component of Zimmer's Rotating Hinge Knee (RHK) System. When used with the RHK System, the Trabecular Metal™ Femoral Cone Augments are for cemented use only. Fixation of all of the cone augments to the femoral implant is accomplished by cementing the internal portion of the augment to the superior side (non-articulating side) of the femoral component. Apposition of the cone to bone inside the medullary canal is with or without cement when used with the LCCK femoral implant and with cement for the RHK femoral implant. The existing, commercially available augments come in three sizes; small, medium and large and three height options. The proposed additional femoral cones will come in the same three sizes: small, medium and large and two height options.