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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.

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.

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 Osseo Ti 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 compatibility of the Persona OsseoTi 3-Peg Patella to the Persona® the Personalized Knee System Posterior Stabilized (PS) femoral components. The addition of this compatibility does not change the intended use or fundamental scientific technology of the device system. The Persona® the Personalized Knee System is a semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial, and patella bones. With this submission compatibility of the Persona OsseoTi 3-Peg patella components will be added to the Persona PS femoral components of the knee system. These patella components articulate against femoral component as part of a total knee system. These patellar components 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.

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 OsseoTi 3-Peq Patella and the associated instruments. 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 of the femoral, tibial, and patellar bones. With this submission a new porous metal backed UHMWPE patella component will be added to the system. These patellar components articulate against femoral component as part of a total knee system. The new patellar components 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. To aid the implantation of these devices several new reusable instruments are also introduced.

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 or uncemented (biological fixation), except for the Persona Osseo Ti Keel Tibia which is for uncemented use only. All other femoral, tibial baseplate and all-polyethylene (UHMVPE and VEHXPE) patella components are indicated for cemented use only.

The purpose of this submission is to add the Personalized Alignment surgical technique indication to the Persona Personalized Knee System

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 kinematic 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 kinematic alignment (KA) surgical technique may only be used with Persona porous and cemented non-porous CR femoral components, Persona CR or UC articular surface components, and the cemented nonporous Persona Natural cemented 5 degree tibial components without a stem extension, Porous coated components may be used cemented or uncemented (biological fixation), except for the Persona porous 0 degree OsseoTi Spiked Keel Tibia which is 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 three new components to the Persona Personalized Knee System. These components consist of a non-porous cemented stemmed tibial baseplate, a porous OsseoTiTM non-cemented tibial baseplate, and a porous plasma sprayed femur. The addition of these components do not change the intended use or fundamental scientific technology of the device system. The Persona 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 plasma sprayed femoral component will be added to the system. These femoral components articulate against tibial and patellar articular surface to form a total knee system. In addition, two new tibial plates will be added, a cemented non-porous stem tibial baseplate and a porous OsseoTiTM stemmed tibial baseplate. All of the new components 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. To aid the implantation of these devices several new reusable instruments are also introduced.

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 kinematic 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 kinematic alignment (KA) surgical technique may only be used with Persona CR femoral components, Persona CR or UC articular surface components, and cemented nonporous Persona tibial components without a stem extension. Porous coated components may be used cemented or uncemented (biological fixation). All other femoral, tibial baseplate, and all-polyethylene (UHMWPE and VEHXPE) patella components are indicated for cemented use only.

Zimmer Inc Persona Personalized Knee System offers Vivacit-E polyethylene components that are sterile packaged with a shelf life of 5 years. The purpose of this submission is to extend the shelf life of these polyethylene components by re-packaging and re-sterilizing unexpired product and product expired up to 3 months post-expiration date. The rework of these devices to extend the shelf life by an additional 5 years does not change the intended use or fundamental scientific technology of the device.

1) Noninflammatory 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 by other techniques 5) Revision procedures where other treatment or devices have failed Porous acetabular shells and femoral stems are indicated for uncemented biological fixation. Non-coated or polyethylene components may be used with mating components that are indicated for either cemented use. Indications for G7® Vivacit-E® Freedom® Constrained Liner: The G7® Vivacit-E® Freedom® Constrained Liner is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of distory of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.

The G7 Acetabular System currently offers a constrained Vitamin E infused highly crosslinked ultra high molecular weight polyethylene (UHMWPE) liner, branded E1 polyethylene, with a preassembled titanium alloy constraining ring. The constrained liner is designed for use in primary or revision total hip arthroplasty (THA) patients that are at a greater risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability. Zimmer Biomet has designed and developed a new constrained liner for use within the G7 Acetabular System, the G7® Vivacit-E® Freedom® Constrained Liner. The purpose of this submission is to obtain clearance for this new constrained liner.