Search Results

The Renovis Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7).The system is indicated for use in the temporary stabilization of the anterior spine during the development of fusion in patients with the following conditions: · degenerative disc disease(DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) - · spondylolisthesis - · trauma (i.e., fracture or dislocation) - · spinal stenosis - · tumor - · pseudoarthrosis - · failed previous fusion WARNING: The Renovis Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

The Renovis Anterior Cervical Plate System consists of various shapes and sizes of plates and screws, and associated instruments. The plates are available in multiple lengths to accommodate single or multi-level surgeries. The plates and screws are manufactured from titanium alloy and the locking clip is manufactured from nickel-titanium alloy.

The Renovis Surgical Hip Replacement System is indicated for patients suffering from: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2. Rheumatoid arthritis; 3. Correction of functional deformity; 4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and 5. Revision procedures where other treatment or devices have failed. The Renovis A400 Hip System is intended for cementless used with the Renovis Cemented Hip Stem.

The subject of this application are Renovis 4.5mm femoral stems (and a 5.25 mm broach) which are an expansion of the FDA cleared Renovis A400 Surgical Hip Joint Replacement Prosthesis (K112897) which is now known as the Renovis Surgical Hip Replacement System. The 4.5mm and 5.25mm femoral stems are the same material, the same configuration and will be offered in the same standard and lateralized offsets, as are the FDA cleared Renovis A400 femoral stems. In addition, this application includes an update of Letter-to-File expansions and changes to the Renovis Surgical Hip Replacement System. Renovis implants and instruments comply with the following material standards: - ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-. 4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications - ASTM A564-13 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes - ASTM F1537-11 Standard Specification for Wrought Cobalt-28Chromium-● 6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539) - ASTM A276-13a Standard Specification for Stainless Steel Bars and Shapes - ASTM A240-14 Standard Specification for Chromium and Chromium-Nickel Stainless Steel Plate, Sheet, and Strip for Pressure Vessels and for General Applications

The Renovis Surgical Hip Replacement System is indicated for patients suffering from: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2. Rheumatoid arthritis; 3. Correction of functional deformity; 4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement. unmanageable using other techniques; and 5. Revision procedures where other treatment or devices have failed.

The Renovis Porous Acetabular Cup System ("Porous shell") are titanium, hemispherical cups consisting of varying sizes (outer diameter of 44 - 66 mm) and screw hole options (no hole shell and cluster hole shells) to accommodate patient anatomy and/or surgical technique. Instrumentation is provided with the system. The Renovis Porous Acetabular Cup System is part of the Renovis Surgical Hip Replacement System and is to be used with Renovis Surgical Hip Replacement System acetabular and femoral components.

The Renovis Lumbar Interbody Fusion (LIF) System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis at the involved level(s). Renovis LIF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The Renovis S128 ALIF System is a stand-alone device and is intended to be used with the cover plate and screws provided and requires no additional supplementary fixation. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided. Should the physician choose to use fewer than the four screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used. The Renovis S134 ALIF System must be used with supplemental fixation cleared by the FDA for use in the lumbar spine.

The purpose of this submission is an additional offering to the Renovis lumbar interbody fusion system portfolio. The S134 Anterior Lumbar Interbody Fusion (ALIF) System implants (cages) are intervertebral body fusion devices with a screw-less design that requires supplemental fixation. The S134 ALIF cages are available in a variety of sizes (widths, height, depths, and bone screw sizes) to suit the individual pathology and anatomical conditions of the patient. The implants are manufactured from PEEK or additively manufactured and machined Titanium. The PEEK markers are manufactured from Tantalum. The Renovis S134 ALIF System cages are to be used with supplemental fixation, and are intended to be used with autogenous bone graft. The Renovis S134 ALIF System is used with device specific instruments including trials. The Renovis S134 ALIF System implants comply with the following material standards: - ASTM F2026-08 Standard Specification for PEEK Polymers for Surgical . Implant Applications - ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications - ASTM F560-08, Standard Specification for Unalloyed Tantalum for Surgical Implant ● Applications The S134 ALIF implants are provided gamma sterilized, and non-sterile (requiring sterilization by the end user).

The Renovis A400 Surgical Hip Replacement System is indicated for patients suffering from: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis: 2. Rheumatoid arthritis; 3. Correction of functional deformity: 4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and 5. Revision procedures where other treatment or devices have failed. The Cemented Hip Stem is intended for cemented applications.

The Renovis Cemented Hip Stem is for use with bone cement only, is offered in multiple sizes, and is manufactured from CoCr. The taper connection of the Renovis Cemented Hip Stem is the same as the existing Renovis FDA cleared Renovis uncemented hip stems (K112897) to allow use with the existing FDA cleared femoral heads (CoCr and ceramic femoral heads; K112897 and K131354). A distal plug and distal centralizers are also offered and are manufactured from PMMA.

The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Renovis S128 ALIF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The Renovis S128 ALIF System is a stand-alone device and is intended to be used with the cover plate and screws provided and requires no additional supplementary fixation. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided. Should the physician choose to use fewer than the four screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used.

The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is cleared under K131122. The SI28 ALIF implants (cages) are to be used with the bone screws and anterior cover plate assembly and requires no additional supplementary fixation systems. The Renovis S128 ALIF System implants are available in a variety of sizes (widths, height, depths, and bone screw sizes; see below) to suit the individual pathology and anatomical conditions of the patient. The implants are manufactured from PEEK or additively manufactured and machined Titanium. The bone screws and cover plate assembly are both manufactured from Titanium alloy. The PEEK markers are manufactured from Tantalum. This Special 510(k) Premarket Notification is submitted for the additional offering of gamma sterilized S128 implants (PEEK cages; titanium cages, screws and cover plates).