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The Vista@-S Device is intended for use in skeletally mature patients with degenerative disc disease (DDD) with/without radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Vista®-S Device is intended for use with supplemental spinal fixation systems and with autogenous bone graft. The Vista S Device is implanted via an anterior approach.

The purpose of this submission is a line extension to the Vista®-S Device adding additional height and footprint options. The Vista -S Device is a box-shaped device for interbody fusion fabricated from polyetheretherketone (PEEK). The device is available in a variety of cross sections and heights to accommodate variations in the individual pathology and anatomic condition of the superior and inferior surfaces of the device contain a pattern of teeth to provide for initial stability. Radiopaque markers are press fit into the device to aid in determining the location of the implant postoperatively.

The TM Ardis® Interbody System is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non-operative treatment. The TM Ardis® Interbody System device is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation.

The TM Ardis® Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine. TM Ardis 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 superior and inferior surfaces of the device are textured to provide increased stability and convex to conform to the vertebral endplates. The device also has two slots on the posterior end to mate with the insertion instrument. The TM Ardis device is wholly comprised of Trabecular Metal Porous Tantalum. Surgical instrumentation for use with the proposed system is fabricated from surgical grade stainless steel and other applicable materials. TM Ardis Interbody System was cleared via 510(k) number K113561 on May 29, 2012. The TM Ardis® Inserter instrument, that is the subject of this premarket notification, is intended for use with the TM Ardis® Interbody System. This instrument is designed specifically for use with the TM Ardis® Implants and is considered an accessory to the implants.

The Trabecular Metal LCCK Coupled Tibial Cones 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 - Legacy Constrained Condylar Knee System, the Trabecular Metal Coupled Tibial Cones are for cementless or cemented use.

The NexGen® LCCK Trabecular Metal™ Coupled Tibial Cones™ are manufactured of Trabecular Metal™, porous tantalum with titanium alloy screws and screw inserts. The proposed TM Coupled Tibial Cones intend to combine the function of TM Tibial Augments and TM Tibial Cone Augments. The TM Coupled Tibial Cone design uses the same cavitary filling geometries of the TM Tibial Cone Augment and the mating functions of the TM Tibial Augment to specifically address small to medium segmented, contained, cavitary bony defects of the proximal tibia found during revision surgery. The TM Coupled Tibial Cone design provides the use of mechanical attachment to the tibial baseplate to allow for modularity and intra-operative assembly. The design is intended to provide stability to the tibial baseplate construct after reconstruction of the proximal tibia when subjected to normal gait activities.

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.

The TM Ardis® Interbody System is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies: Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non-operative treatment. The TM Ardis® Interbody System device is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation.

The TM Ardis® Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine. TM Ardis is designed for fusing the adjacent bony surfaces and may be used to replace a disc at one or two contiguous levels in L2-SI. The superior and inferior surfaces of the device are textured to provide increased stability and convex to conform to the vertebral endplates. The device also has two slots on the posterior end to mate with the insertion instrument. The TM Ardis device is wholly comprised of Trabecular Metal Porous Tantalum. Surgical instrumentation for use with the proposed system will be fabricated from surgical grade stainless steel and other applicable materials.

The Vista S Device is intended for use in skeletally mature patients with degenerative disc disease (DDD) with/without radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Vista® S Device is intended for use with supplemental spinal fixation systems and with autogenous bone graft. The Vista -S Device is implanted via an anterior approach. The Vista -S Device is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-L5) for partial replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Vista -S Device is intended for use with supplemental internal spinal fixation systems. The Vista -S Device may be used with bone graft.

The Vista -- S Device is a box-shaped device for interbody fusion and vertebral body replacement fabricated from polyetheretherketone (PEEK). The Vista -S 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 a cervical interbody fusion device at one level from C2-T1. 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. The superior and inferior surfaces of the device contain a pattern of teeth to provide for initial stability. Radiopaque markers are press fit into the device to aid in determining the location of the implant postoperatively.

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.

The Trabecular Metal Fusion Device is a cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with/ without radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of nonoperative treatment. The Trabecular Metal Fusion Device is intended for use with supplemental fixation systems and with autogenous bone graft. The Trabecular Metal Fusion Device is implanted via an anterior approach.

The Trabecular Metal™ Fusion Device is an interbody fusion device comprised wholly of Trabecular Metal. The Trabecular Metal™ Fusion Device is implanted in the cervical intervertebral disc space and is intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height, and preventing the collapsing of one vertebrae onto another. The Trabecular Metal™ Fusion Device is offered in three cross sectional sizes and is available in various height options to accommodate variations in patient anatomy. The height is measured at the posterior aspect of the device is tranezoidal in shane and is offered in lordotic and non-lordotic configurations, i.e., with 7 degree and 0 degree profiles. The superior and inferior surfaces of the device have a pattern of ripples and a central hole in the device extending in the superior-inferior direction for placement of bone graft. Additionally, certain parts of the proposed system contain a central slot on the anterior surface to allow interface with a central inserter.

Trabecular Metal Tibial 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 Tibial Cone Augments are for cemented use only. When used with the NexGen Complete Knee Solution - Legacy Constrained Condylar Knee System, the Trabecular Metal Tibial Cone Augments are for cementless or cemented use.

The existing, commercially available NexGen® Trabecular Metal™ Tibial Cone Augments are manufactured wholly of Trabecular Metal porous tantalum, the same material that comprises numerous medical devices intended for use in orthopedic applications. The devices which are the subject of this 510(k), the modified NexGen Trabecular Metal Tibial Cone Augments are also manufactured of the same Trabecular Metal material, using the same methods as the predicate device. The existing, commercially available NexGen Trabecular Metal Tibial Cone Augments have tapered posterior, medial and lateral walls. The periphery of the inferior surface is smaller than that of the superior surface. A similar taper pattern is also present in the modified tibial cones. Both the modified tibial cones augments and the existing, commercially available tibial cone augments are to be used in conjunction with Zimmer's NexGen® Complete Knee Systems- both the Legacy® Constrained Condylar Knee (LCCK) Stemmed Tibial Bases and the tibial component of Zimmer's Rotating Hinge Knee (RHK) System. Fixation of all of the cone augments to the tibial implant is accomplished by cementing the superior portion of the augment to the underside of the tibial baseplate. Apposition of the cone to bone inside the medullary canal is with or without cement when used with the LCCK tibial implant and with cement for the RHK tibial implant. With all of these tibial cone augments the LCCK tibial baseplate inferior surface must be cemented to the bone and the required stem extensions can either be cemented or press-fit. The existing, commercially available augments come in four medium & large sizes, two height options and stepped augments. They can be used in conjunction with Zimmer's LCCK or RHK Knee Systems.

The Trabecular Metal Vertebral Body Replacement System is comprised of vertebral body replacement devices intended for use in thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Trabecular Metal Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Trabecular Metal Vertebral Body Replacement may be used with bone graft.

The existing, commercially available Trabecular Metal Vertebral Body Reconstruction System is intended for use in thoracolumbar (TI-L5) surgical cases to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Trabecular Metal Vertebral Body Reconstruction System is wholly comprised of Trabecular Metal Porous Tantalum (tantalum deposited on a vitreous carbon skeleton) and is available in a variety of configurations to accommodate the anatomical requirements of different patients. The Trabecular Metal Vertebral Body Replacement System Instrumentation Set which is the subject of this premarket notification is intended for use in these thoracolumbar surgical cases and facilitates the implantation of the Trabecular Metal Vertebral Body Replacement implant system. The provisionals size the surgical site in order to determine the appropriate TM-400 implant size. The straight inserter and tamp facilitate implantation of the TM-400 implant via anterior or lateral lumbar approach. All instruments included in the set are made from 17-4 stainless steel.