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The Zimmer Biomet Ceramic Heads are indicated for the following conditions: (1) a severely painful and/or disabled hip joint as a result of osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia, (2) avascular necrosis of the femoral head, (3) acute traumatic fracture of the femoral head or neck, (4) failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement, (5) certain cases of ankylosis, (6) nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. When used with constrained acetabular liners, the Zimmer Biomet Ceramic Heads are intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.

The Zimmer Biomet Ceramic Heads are made from a composite ceramic containing approximately 75% alumina (Al2O3) and 25% zirconia (ZrO2) (percentage by weight). They are supplied with a 12/14 bore or a Type 1 bore. The scope of the subject submission is limited to the 22.2mm head diameter with multiple neck configurations. The subject ceramic heads are intended for mating with Ti-6Al-4V alloy, Ti-6Al-7Nb alloy stems with tapered necks. They may only be used in combination with highly crosslinked or conventional polyethylene (PE) or metal-back polyethylene liners.

This device is indicated for patients with severe knee pain and disability due to: -Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. -Collagen disorders, and/or avascular necrosis of the femoral condyle. -Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. -Moderate valgus, varus, or flexion deformities. -The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. Porous components may be used cemented or uncemented (biological fixation). Augments may be attached via bone cement or screw to the tibial plates and/or femoral components. Splined stem extension components are intended to be used press-fit (uncemented). All other femoral component, tibial plate, stem extension, and femoral and tibial augment components are indicated for cemented use only.

The purpose of this submission is to add a new component to the Persona Revision Knee System, the component is the Persona Revision SoluTion Femoral Components. The addition of these components do not change the intended use or fundamental scientific technology of the device system. The Persona Revision Knee System is a semiconstrained modular knee prosthesis designed to resurface of the femoral and tibial bones. With this submission a new Ti-6Al-4V femoral component will be added to the system. These femoral components articulate against an articular surface of the tibial component, as well as, a pat of a total knee system. The new femoral components are compatible with a variety of augments, cones, and stem extent of sizes to match the needs of a patient's anatomy when performing total knee arthroplasty. These components are provided sterile and single use.

The Affixus® Tibial Nailing System is indicated for temporary stabilization of tibial fractures and osteotomies including proximal, metaphyseal, and distal shaft fractures, closed fractures, open fractures, pathologic fractures, non-unions, malunions and deformity corrections.

The Affixus Tibial Nalling System is a long bone nailing system that offer implants designed to treat a range of tibial fractures from simple to complex, with versatile locking options. They restore the shape of preinjured bone and are available in a variety of lengths and diameters to meet assorted anatomical needs. Screws and End Caps are included in the system. All implants are made of Ti-6Al-4V. The Affixus platform of instrumentation is designed to provide options and flexibility for many intraoperative approaches while maintaining ease of use and commonality. This submission introduces 4mm Cortical Bone Screws are also made of Ti-6AL-4V and feature a double-lead thread design with a self-tapping tip. Screw options include Ø4mm: 20mm - 60mm, increments of 2 mm 60mm - 90mm, increments of 5mm Note: 4mm Screws are inserted through distal locking holes of 8mm Tibia nails only.

When a mechanical alignment approach is utilized, this device is indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. - Collagen disorders, and/or avascular necrosis of the femoral condyle. - Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. - Moderate valgus, varus, or flexion deformities. - The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. When a personalized alignment approach is utilized, this device is indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. - Collagen disorders, and/or avascular necrosis of the femoral condyle. - Moderate valgus, varus, or flexion deformities.

The Persona Personalized Knee System is a semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial, and patellar bones. The purpose of this submission is to add compatibility for cemented nonporous Persona tibial components with a stem extension to the current Personalized Alignment (PA) surgical technique option. In addition to the modifications regarding personalized alignment, this submission also discusses the updated geometric evaluations for the Persona Personalized Knee System as well as the shelf-life extension (5 years to 10 years) of its Vivacit-E VEXLPE implant components.

Anatomic Total Shoulder Applications: · Osteoarthritis • The patient must be anatomically and structurally suited, as evident by scapula and proximal humerus closure, to receive the implants. OsseoFit™ Stemless Shoulder humeral components have a porous surface and are indicated for uncemented biological fixation applications. Compatible Glenoid components are intended to be implanted with bone cement. The porous posts may be inserted without bone cement. Compatible Convertible Glenoid Baseplate components are intended for cementless applications with the addition of screw fixation.

The OsseoFit™ Stemless Shoulder System consists of a stemless humeral head adapter for anatomic total shoulder applications. The OsseoFit humeral implant is an anatomical (left/right specific), asymmetric humeral anchor with six fins whose location, length, and height vary. The OsseoFit humeral implants are available in Onlay and Inlay variants. The Onlay implants sit on top of the prepared bone while the Inlay implants have a dished superior portion with a shorter fin length to sit within the bone. The OsseoFit Humeral Implant also includes anterior suture holes for soft tissue attachment. The humeral implants are manufactured through additive manufacturing which includes areas of OsseoTi porous technology to allow biological fixation. The OsseoFit Stemless Shoulder System is intended for cementless applications and is designed to be used with a compatible Identity Shoulder System (K213856) humeral head. The Identity Humeral Head is assembled to the OsseoFit Humeral Head Adapter via a locking taper by a disposable impactor that is packaged together with the head adapter. The Identity heads can be used with a compatible Alliance Glenoid Implant (K191814 and K193180) or Comprehensive Convertible Baseplate liner (K211729).

When a mechanical alignment approach is utilized, this device is indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. - Collagen disorders, and/or avascular necrosis of the femoral condyle. - Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. - Moderate valgus, varus, or flexion deformities. - The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. When a Personalized Alignment approach is utilized, this device is indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. - Collagen disorders, and/or avascular necrosis of the femoral condyle. - Moderate valgus, varus, or flexion deformities. The Personalized Alignment (PA) surgical technique may only be used with Persona cemented and uncemented CR femoral components, Persona CR, Ultra Congruent (UC), and Medial Congruent (MC) articular surface components, the Persona Cemented Stemmed tibial components without a stem extension, and the Persona OsseoTi Keel Tibia and Cemented Keel Tibia. Porous coated components may be used cemented (biological fixation), except for the Persona OsseoTi Keel Tibia and the Persona OsseoTi 3-Peg Patella which are for uncemented use only. All other femoral, tibial baseplate and all-polyethylene (UHMWPE and VEHXPE) patella components are indicated for cemented use only.

The purpose of this submission is to add a new component to the Personalized Knee System, the component is the Persona Ti-Nidium PPS Femurs. The addition of these components do not change the intended use or fundamental scientific technology of the device system. The Personalized Knee System is a semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial, and patellar bones. With this submission a new porous coated Ti-6Al-4V femoral component will be added to the system. These femoral components articular surface of the tibial component, as well as, a patellar component, as part of a total knee system. The new femoral come in a variety of sizes to match the needs of a patient's anatomy when performing total knee arthroplasty. These components are provided sterile and single use.