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The A200 Knee System is intended for use in total knee arthroplasty for the following indications: 1. Painful and disabled knee joint resulting from osteoarthritis, traumatic arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. This device is for cemented use only.

The Renovis A200 PS Knee System is a patellofemorotibial polymer/metal/polymer semiconstrained prosthesis intended to be implanted to replace a knee joint. The system consists of femoral, tibial and patella components intended for use with bone cement. The subject of this 510k Premarket Notification are additional offerings to the Renovis A200 Knee System (K120038) resulting from customer requests to better meet patient need (anatomy and surgical technique). The additional offerings are part of the FDA cleared A200 Knee System and are called the A200 PS Knee System. The PS Knee System is a primary, posterior stabilized (PS), tri-compartmental knee replacement system to treat knee disorders resulting from degenerative diseases where the posterior cruciate ligament is absent. The new A200 PS Knee System includes: - Femoral components in nine (9) sizes (1, 2, 3, 3N, 4, 4N, 5, 6, and 7) in a posterior stabilized (PS) design, each for left and right sides, manufactured from CoCrMo in compliance with ASTM F75-18 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants - Tibial insert components in three (3) footprint sizes; each for the left and right sides; with articulating thicknesses ranging from 10 mm to 23 mm; in two levels of constraint - PS and PS Plus. The tibial inserts have a mechanical lock to the tray (snap mechanism). Tibial inserts are manufactured from highly cross-linked UHMWPE (with and without 0.1% by wt Vit E), and 1020 UHMWPE in compliance with ASTM F648-14 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants and ASTM F2695 -12 Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications - Patellar components in five (5) sizes in sombrero and five (5) sizes in domed design. Patellar components are manufactured from highly cross-linked UHMWPE (with and without 0.1% by wt Vit E), and 1020 UHMWPE in compliance with ASTM F648-14 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants and ASTM F2695 -12 Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications - FDA cleared (K120038) Tibial tray (baseplate) components in (9) sizes, each for the left and right sides, and in each in two designs, a conical design (CoCrMo) and a keeled design (Ti6A14V) The system also includes reusable instrumentation.

The Renovis Tesera SC Stand-alone ACF System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2-T1. Renovis Tesera SC Stand-alone ACF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation. The Renovis Tesera SC Stand-alone ACF System is a stand-alone system when used with the cover plate and screws provided, and requires no additional supplemental fixation. When used as a stand-alone system, the cages require the use of three (3) screws and the cover plate assembly. When used without the cover plate and three screws the Renovis Tesera SC Stand-alone ACF System is a non-stand-alone system and requires additional supplemental fixation cleared by the FDA for use in the cervical spine to augment stability. The Renovis Tesera C ACF System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2-T1. Renovis Tesera C ACF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation. The Renovis Tesera C ACF System is a non-stand-alone system and requires additional supplemental fixation cleared by the FDA for use in the cervical spine to augment stability.

Tesera (or T3) describes Renovis' proprietary Tesera Trabecular Technology™ Porous Structure for the manufacture of the porous titanium on the superior and inferior surfaces of the implant. The Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System is a single, cervical implant System that includes two (2) "subsystems", the: - Renovis Tesera C Anterior Cervical Fusion (ACF) System - Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System . The Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System cages are additively manufactured from Ti-6Al-4V and are available in a variety of sizes (widths, heights, and lordotic angles) to suit the individual pathology and anatomical conditions of the patient. The Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System includes cages, and existing bone screws (self-drilling and self-tapping options) and anterior cover plate assembly. When used with the cover plate and screws, the Tesera SC ACF System cages require no supplementary fixation systems. The screws protrude through the interbody portion of the device into the adjacent vertebral bodies. The cages have windows in the side for visualization of the bone graft. When used without the cover plate and three screws the Renovis Tesera SC Stand-alone ACF cages require supplemental fixation. The Renovis Tesera C Anterior Cervical Fusion (ACF) System is not stand alone and requires supplemental fixation. The Renovis Tesera C/Tesera SC ACF System cages comply with ASTM F2924-14 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion. The system also consists of reusable instrumentation. The instruments comply with ASTM A564/A64M-13e1 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes or ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.

The Renovis S180 Lateral Lumbar Interbody Fusion 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 at the involved level(s). Patients should be skeletally mature and have at least six months of non-operative treatment with the devices. The Renovis S180 System must be used with supplemental fixation cleared by FDA for use in the lumbar spine. Renovis S180 System implants are to be used with autogenous bone graft.

The Renovis S180 Lateral Lumbar Interbody System is an additional offering to the Renovis system of interbody fusion devices. This application describes changes in lengths, widths, heights and lordosis configurations; material standard; packaging; and additive manufacturing device. The S180 LLIF System includes cages of a variety of lengths, widths, heights, and lordosis to suit the individual pathology and anatomical conditions of the patient. The different shape of the footprint allows for a lateral surgical approach for insertion. The S180 LLIF System cages are manufactured from Ti6A14V compliant with ASTM F2924 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion. The system also includes instruments which are manufactured from Stainless steel and Ti-6Al-4V.

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. Supplemental fixation, cleared by the FDA for use in the lumbosacral spine, must be used with implants ≥20°.

The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is FDA cleared as K131122 and K140106 (sterile implants). This application describes additional cages offerings (new lengths, widths, and lordosis) and a packaging change. The S128 ALIF System includes cages of a variety of lengths, widths, heights, and lordosis to suit the individual pathology and anatomical conditions of the patient. The different shape of the footprint allows for different surgical approaches for insertion. S128 ALIF System cages are standalone for devices <20° when implanted with the coverplate and screws. Implants are offered in Ti6A14V and PEEK with Tantalum marker pins. Titanium cages are additively manufactured then machined to the final cage dimensions. PEEK implants are manufactured using traditional methods. The Ti6Al4V conforms to the chemical and mechanical requirements of ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications The PEEK is compliant with ASTM F2026-17 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications.The Tantalum is compliant with ASTM F560-17 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications. The S128 ALIF System cages that are the subject of this application are gamma sterilized. The system also includes instruments to allow for implant determination, trialing and disc preparation. Instruments are manufactured from stainless steel in compliance with ASTM A564/M564-13e1 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes.

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 applications unless used with the Renovis Cemented Hip Stem. The Renovis Surgical Porous Coated Acetabular Shell System is intended for cementless applications. The Cemented Hip Stem is intended for cemented applications. The Renovis Tesera Trabecular Technologies (T3) Acetabular Shell System is intended for cementless applications. The Bipolar Head is for use in conjunction with Renovis femoral heads and femoral stems. Bipolar outer heads are not for use with acetabular shells and liners.

The subject of this application is Renovis Extended Lateral Offset Femoral Stems which are an expansion of the FDA cleared Renovis Surgical Hip Replacement System. Extended Lateral Offset Femoral Stems are provided in a variety of sizes to fit patient need. This application also includes a new device specific neck trial and X-ray template, and additional implants and instruments. The Extended Lateral Offset Femoral Stems are manufactured from the same material as other FDA cleared Renovis femoral stems. The instruments are manufactured from the same material as other instruments included in FDA cleared submissions.

The Renovis S141 Lumbar Interbody Fusion 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 at the involved level(s). Renovis S141 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 S141 System must be used with supplemental fixation cleared by FDA for use in the lumbar spine.

The Renovis S141 Lumbar Interbody Cage System is FDA cleared as K143126. This application describes a manufacturing change to the K143126 S141 Ti6Al4Vcages; internal dimensional changes; additional cages geometries; and a packaging change. The new name of the system is the Renovis S141 Lumbar Interbody Fusion System (S141 System). The S141 System includes cages of a variety of lengths, widths, heights, and lordosis to suit the individual pathology and anatomical conditions of the patient. The different shape of the footprint allows for different surgical approaches for insertion. The Ti6Al4V is compliant with ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. The system also includes instruments which are manufactured from stainless steel in compliance with ASTM A564-13 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes.

The Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2-T1. Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation. The Renovis Tesera SC ACF System is a stand-alone system when used with the cover plate and screws provided, and requires no additional supplemental fixation. When used as a stand-alone system, the cages require the use of three (3) screws and the cover plate assembly. When used without the cover plate and three screws the Renovis Tesera SC ACF System is a non-stand-alone system and requires additional supplemental fixation cleared by the FDA for use in the cervical spine to augment stability.

The Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System includes the Tesera Trabecular Titanium (T3) cages, bone screws (self-drilling and self-tapping options) and anterior cover plate assembly. When used with the cover plate and screws, the Tesera SC ACF System requires no supplementary fixation systems. The screws protrude through the interbody portion of the device into the adjacent vertebral bodies, stabilize the vertebral body and reduce the likelihood of expulsion of the implant. The Tesera Trabecular Titanium (T3) cages have windows in the side for visualization of the bone graft. The accompanying cover plate is designed to resist screw back-out and must be used when the screws are implanted. When used without the cover plate and screws, the Tesera SC ACF cages require supplemental fixation. The Renovis Tesera SC ACF System 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 cages are additively manufactured then machined from Titanium alloy (Ti-6A1-4V). The bone screws are manufactured from Titanium alloy (Ti-6Al-4V) and the cover plate assembly is manufactured from Titanium alloy (Ti-6Al-4V) and Nitinol alloy. The implants are provided to the end user sterilized through gamma irradiation. The system also consists of reusable instrumentation used to implant the cages, screws, and cover plate assembly.

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 S141 Lumbar Interbody Cage 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 at the involved level(s). Renovis S141 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 S141 System must be used with supplemental fixation cleared by FDA for use in the lumbar spine.

The Renovis S141 Lumbar Interbody Cage System consist of 3 designs and each design is available in either PEEK or titanium alloy. The PLIF implants are available as a lordotic form, while the OLIF implants are provided with no lordosis. The implants are available in various heights and lengths to accommodate patients' anatomy. The implants are provided sterile, and a set of instrument for implantation is provided to facilitate implantation. Two radiographic markers made of tantalum per ASTM F650 are included in the PLIF and OLIF PEEK implants, and three radiographic markers made of tantalum per ASTM F560 are included in the TLIF PEEK implant to allow radiographic visualization.