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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.

The Affixus® Tibial Nailing System is indicated for temporary stabilization and fixation 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® Antegrade Femoral Nailing System is indicated for temporary stabilization and fixation of femoral fractures and osteotomies including proximal, metaphyseal, and distal shaft fractures, trochanteric and subtrochanteric fractures, closed fractures, pathologic fractures, non-unions, malunions and deformity corrections.

The Affixus Tibial Nailing System and the Affixus Antegrade Femoral (AF) Nailing System are long bone nailing systems that offer implants designed to treat a range of tibial and femoral 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.

Hemiarthoplasty/Conventional Total Application: · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. - Rheumatoid arthritis. - · Correction of functional deformity. · Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. • Difficult clinical management problems, including cuff arthropathy, where other may not be suitable or may be inadequate. Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure. Reverse Application: Zimmer Biomet Reverse Shoulder products are in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Zimmer Biomet Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component or reverse components for total shoulder arthroplasty (conventional or reverse applications). The humeral components may be used cemented or uncemented (biological fixation). The Titanium Humeral Head and Glenosphere components are indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head or Glenospheres is not recommended for patients who lack suspected material sensitivity to cobalt alloy.

The Identity Shoulder System cleared previously in K213856 is a comprehensive collection of components designed with the intention of providing the modularity and adaptability necessary to facilitate individual anatomical adjustment and restoration of the glenohumeral joint during shoulder arthroplasty. The Identity Shoulder System in the anatomic configuration is comprised of several individual components such as Humeral Stem, Fixed Angle Humeral Stem Adapter, Humeral Head. This configuration can be used as a hemi-athroplasty with the humeral head articulating against the natural glenoid bone or as an anatomic total shoulder replacement with a compatible glenoid component. The components of the Identity Shoulder System may also be used in the reverse configuration. Individual components include a Humeral Stem, Humeral Tray and Humeral Bearing, This construct is intended to be used with a compatible glenosphere/baseplate component. The current 510(k) is for additional sizes/styles of humeral trays and bearings for the reverse configuration. Extra Extended trays in 3 heights in a neutral configuration are being additional lateralization. A uniforn thickness bearing is also being added in an effort to improve internal/external range of motion and reduce potential of scapular notching.

Hemiarthoplasty/Conventional Total Application: - · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. - · Rheumatoid arthritis. - · Correction of functional deformity. - · Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. · Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate. Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure. Reverse Application: Zimmer Biomet Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically suited to receive the implants and a functional deltoid muscle is necessary. The Zimmer Biomet Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component or reverse components for total shoulder arthroplasty (conventional or reverse applications). The humeral components may be used cemented or uncemented (biological fixation). The Titanium Humeral Head and Glenosphere components are indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head or Glenospheres not recommended for patients who lack suspected material sensitivity to cobalt alloy.

The Identity Shoulder System is a comprehensive collection of components designed with the intention of providing the modularity and adaptability necessary to facilitate individual anatomical adjustment and restoration of the glenohumeral joint during shoulder arthroplasty. The Identity Shoulder System in the anatomic configuration is comprises of several individual components such as Humeral Stem, Fixed Angle Humeral Stem Adapter, Humeral Head Adapter, and Humeral Head. This configuration can be used as a hemiarthroplasty with the humeral head articulating against the natural glenoid bone or as an anatomic total shoulder replacement with a compatible glenoid component. The components of the Identity Shoulder System may also be used in the reverse configuration. Individual components include a Humeral Stem, Humeral Tray and Humeral Bearing. This constructed is intended to be used with a compatible glenospheres/baseplate component.

- 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. - 2. Rheumatoid arthritis. - 3. Correction of functional deformity. - 4. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. - 5. Difficult clinical management problems, where other methods of treatment may not be inadequate. Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure. The Alliance Monoblock glenoid components are indicated for cemented application only. The Alliance Modular Glenoid components are intended to be implanted with bone cement. The TM and porous posts may be inserted without bone cement.

The Alliance Glenoid system is a series of glenoid components which includes previously cleared (K191814) monoblock glenoids with 2 or 3 pegs and modular glenoids with 3 or 4 pegs. In addition to the predicate neutral (flat) modular 4-pegged design, an augmented configuration for correction of glenoid bone defects is being added to the product line. All glenoid types are available in various sizes. The posts of the modular glenoids are made of either a Tivanium® substrate with Trabecular Metal (TM) sleeve or the Tivanium® substrate with Porous Plasma Spray (PPS) coating. The Alliance Glenoids are intended to be used with existing humeral stem and head components to complete a total shoulder replacement construct.

- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. - Rheumatoid arthritis. - Correction of functional deformity. - Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. - Revision procedures where other treatment or devices have failed. - Dislocation risks. Dual Mobility Hip Bearings are single-use implants, intended for uncemented applications.

The G7 Dual Mobility System and Active Articulation System are dual articulation systems wherein there are two articulating surfaces in the same joint space. The systems include a polyethylene (UHMWPE) bearing which is assembled over a femoral head. The femoral head articulates on the inner, concave surface of the bearing. The resultant assembly then articulates within a metal liner (G7 Dual Mobility System) or acetabular shell (Active Articulation System). The G7 Dual Mobility and Active Articulation Systems are designed for both primary and revision surgeries, where all device components associated with the wear couple are removed and replaced.

- 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. - 2. Rheumatoid arthritis. - 3. Correction of functional deformity. - 4. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. - 5. Difficult clinical management problems, where other methods of treatment may not be suitable or may be inadequate. Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure. The Alliance Monoblock Glenoid components are indicated for cemented application only. The Alliance Modular Glenoid components are intended to be implanted with bone cement. The TM and porous posts may be inserted without bone cement.

The Alliance Glenoid is a series of glenoid components which includes monoblock polyethylene glenoids with 2 or 3 pegs and modular glenoids with 3 or 4 pegs glenoids. All glenoid types are available in various sizes. The central posts of the modular glenoids are made of either a Tivanium® substrate with Trabecular Metal (TM) sleeve or the Tivanium substrate with Porous Plasma Spray (PPS) coating. The Alliance Glenoids are intended to be used with existing humeral stem and head components to complete a total shoulder replacement construct.

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 Persona Revision Knee System is a semi-constrained total knee prosthesis consisting of anatomically shaped components designed to resurface the articulating surface of the femoral and tibial bones including: - Femoral components - Articular surfaces - Tibial components - Stem extensions - Femoral and tibial augments - Femoral and tibial cones. The large modularity of the componentry of the Persona Revision knee system including articular surfaces with different levels of constraint, augments, cones and stem extensions provides numerous possible configurations to optimally address the bone and joint condition of the patient in a primary or revision TKA surgery. The Persona Revision Knee System also includes nonimplantable tools, or instrumentation, that facilitate the implantation of above described implant components as well as cases and trays to hold these instruments during sterilization and their subsequent storage.

1. Painful and disabled knee joint resulting from osteoarthritis, or traumatic arthritis, or 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 total joint replacement procedure. Femoral components and tibial tray components with porous coatings are indicated for cemented biological fixation application. Non-coated (Interlok) femoral components and all polyethylene patellar components are indicated for cemented application only.

The Vanguard XP Knee System is a total knee replacement system that consists of a femoral component composed of cobalt-chromium-molybdenum (Co-Cr-Mo), two styles of tibial trays manufactured out of Co-Cr-Mo (with locking bar), and dual bearings machined of Vivacit-E Vitamin-E Highly Crosslinked Polyethylene (VEHXPE). Biomet patellae can be used with the Vanguard XP Knee System. The subject Vanguard XP tibial components are available with a porous plasma spray (PPS®) of titanium alloy powder for uncemented or cemented fixation or with Biomet's Interlok coarse blasted finish for cemented fixation only. The Vanguard XP Knee System offers the flexibility to retain the ACL and PCL ligaments, retain just the PCL ligament and accommodate an intact, partially functioning PCL within a single system.