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The PSPS bone model is indicated, based on patient-specific radiological images (CT scans), to assist in pre-operative orthopedic planning for patients able to undergo orthopedic procedures and able to be radiologically scanned. The PSPS bone model is a diagnostic tool to visually aid in orthopedic pre-operative surgical planning for skeletally mature individuals. Be advised, the quality of medical images determines the accuracy of the 3D bone models. Zimmer Biomet recommends using CT Protocol PMI® Patient-Matched Implants CT Protocol. Only images obtained less than six (6) months prior should be used for simulating and/or evaluating orthopedic treatment options.

The Patient Specific Planning Solution™ 3D Bone Model is a 3-dimensional representation of the requested anatomical bone site. The Bone Models are diagnostic tools to allow the Surgeon to physically and visually aid in pre-operative orthopedic planning to facilitate the implantation of medical devices. The Patient Specific Planning Solutions™ are designed of polyamide (nylon) using additive manufacturing (selective laser sintering), based on the approved/finalized orthopedic pre-surgical plan and shipped prior to surgery. The Bone Models are provided non-sterile and are used pre-operatively for education, planning to aid in component selection, sizing, and placement based on patient specific radiological images (CT scan). Physical bone models' critical bony areas are printed at <1mm mean deviation. The full-scale 3D printed Patient Specific Bone Model is shipped to the patient's surgery to facilitate pre-operative planning.

Biomet Comprehensive 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 suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive 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. Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation. Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coating are indicated for either cemented or uncemented biological fixation applications. Biomet Comprehensive 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 Comprehensive 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. Titanium glenospheres are intents with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy. Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation. Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coating are indicated for either cemented or uncemented biological fixation applications. 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, 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. Humeral components with a porous coated surface coating are indicated for either cemented biological fixation applications. The Comprehensive® Modular Hybrid® Glenoid is intended to be implanted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement. The Comprehensive Humeral Positioning Sleeves are for cemented use only and are intended for use with the Comprehensive Fracture Stem. The Versa-Dial Humeral Head Prosthesis is intended for use only with the Comprehensive Shoulder Stems (Fracture, Primary and Revision), and the glenoid components of the Comprehensive Shoulder System. The Titanium Versa-Dial Humeral Head Prosthesis is 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 is not recommended for patients who lack suspected material sensitivity to cobalt alloy* *The Titanium Versa-Dial Humeral Head Prosthesis is not for sale in Canada Anatomic Applications 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Revision where other devices or treatments have failed. 4. Correction of functional deformity. 5. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. 6. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may be suitable or may be inadequate. Reverse Applications The Comprehensive Reverse Shoulder is 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 and structurally suited to receive the implants and a functional deltoid muscle is necessary. Comprehensive Convertible Glenoid Baseplate components are intended for cementless applications with the addition of screw fixation. Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented application. Huments with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications. Biomet Comprehensive Reverse Shoulder products are in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy 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 Comprehensive 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. Titanium glenospheres are intended for patients with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy. Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixations. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation. Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

Comprehensive Shoulder System consists of partial and total shoulder replacement components use in cemented and uncemented applications. The devices are modular components consisting of humeral stems, modular heads and glenoid components for anatomic and humeral tray and glenosphere components for reverse configuration. The purpose of the current submission is to add MR Conditional labeling.

Anatomic Applications 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Revision where other devices or treatments have failed. 4. Correction of functional deformity. 5. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. 6. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate. Reverse Applications The Comprehensive Reverse Shoulder is 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 and structurally suited to receive the implants and a functional deltoid muscle is neeessary. Comprehensive Convertible Glenoid Baseplate components are intended for cementless applications with the addition of screw fixation. Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented application. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

The proposed device is an orthopaedic total joint intended to replace the damaged or diseased natural shoulder joint in shoulder arthroplasty to provide pain relief and restore function. It is modular in design, consisting of a baseplate held to the bone with bone screws and a modular liner. The device is designed to be implanted as the glenoid component of an anatomic total shoulder with the option to convert to a reverse shoulder configuration without removal of the metal components. The current submission is to expand the product offering by the addition of a liner manufactured from Vivacit-E Vitamin E Highly Crosslinked Polyethylene (VEHXPE).

Biomet Comprehensive Vault Reconstruction System Components 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 Comprehensive Vault Reconstruction System Component 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 Comprehensive Vault Reconstruction System glenoid baseplate components are intended for cementless application with the addition of screw fixation in patients with unusual anatomy and/or extensive bone loss which precludes the use of a standard glenoid baseplate component. Titanium glenospheres are intended for patients with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy. Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coating are indicated for either cemented or uncemented biological fixation applications.

The Comprehensive Vault Reconstruction System is a glenoid baseplate for reverse shoulder arthroplasty designed to match the natural geometry of an individual patient.

- 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, 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. Humeral components with a porous coated surface coating are indicated for either cemented biological fixation applications. The Comprehensive Modular Hybrid Glenoid is intended to be implanted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement. The Comprehensive Humeral Positioning Sleeves are for cemented use only and are intended for use with the Comprehensive Fracture Stem. The Versa-Dial Humeral Head Prosthesis is intended for use only with the Comprehensive Shoulder Stems (Fracture, Primary and Revision), and the glenoid components of the Comprehensive Shoulder System. The Titanium Versa-Dial Humeral Head Prosthesis is 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 is not recommended for patients who lack suspected material sensitivity to cobalt alloy.

Comprehensive Shoulder System consists of partial and total shoulder replacement components use in cemented and uncemented applications. The devices are modular components consisting of humeral stems, modular heads and glenoid components.

1. Primary total shoulder arthroplasty. 2. Non-inflammatory degenerative joint disease including osteoarthritis Comprehensive Nano Stemless Shoulder humeral components have a porous coated surface coating and are indicated for uncemented biological fixation applications. The Comprehensive Modular Hybrid Glenoid is intended to be implanted with bone cement. The porous titanium peg may be inserted without bone cement.

The Comprehensive Nano Stemless Shoulder is part of the Comprehensive Shoulder System intended for use in total shoulder arthroplasty. The humeral component is used as part of an anatomic configuration with a Versa-Dial® humeral head that articulates against the Comprehensive hybrid glenoid component. The head is connected to the Nano humeral component by a taper adaptor. The Comprehensive Nano Stemless Shoulder is manufactured from Ti6Al4V alloy. It consists of a central tapered region and six outer wings. The taper has a machine finish and accepts the taper adaptor of the humeral head component. The bone-contacting outer surface features a porous coating of plasma sprayed titanium alloy for cementless fixation in the proximal humerus. Six sizes are available - 30 mm through 40mm in 2mm increments.

Comprehensive 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 and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive 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. Titanium glenospheres are intended for patients with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy. Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation. Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

The devices are a line extension of the Comprehensive Reverse Shoulder System and consists of new 36mm and 40mm tray and liner locking mechanism designs as well a a new 40mm glenosphere. The highly cross-linked ultrahigh molecular weight (HXPE) polyethylene liners are offered either in Prolong® (Standard) or Vivacit-E (Vitamin E). The tray taper geometry as well as the material (Ti-6AL-4V and Co-28Cr-6Mo) and thickness offerings are identical (standard, +5mm, +10mm) to the predicate. The trays will still be offered with a centric (standard) taper as well as two other offset tapers (+3 and +6) to provide more offerings to the surgeon.

Indications For Use: The Comprehensive Segmental Revision System is intended for use in cases of: - 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. - 2. Rheumatoid arthritis. - 3. Revision where other devices or treatments have failed. - 4. Correction of functional deformity. - 5. Oncology applications including bone loss due to tumor resection. When used in a proximal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for: Treatment of acute or chronic fractures with humeral head (shoulder) involvement, which are unmanageable using other treatment methods. When used as a distal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for: Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement, which are unmanageable using other treatment methods. Biomet Comprehensive Segmental Revision System is indicated for use in a reverse application 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. Reverse application is limited to proximal humeral replacement in the United States. The Comprehensive Segmental Revision System is intended for use with or without bone cement in the proximal shoulder. The Comprehensive Segmental Revision System is intended for use with bone cement in distal humeral applications. Tissue Attachment Augments provide the option for tissue stabilization and attachment.

The Comprehensive Segmental Revision System (SRS) is a multi-piece orthopedic implant designed to replace the shoulder joint. The device is designed specifically for use in cases where there is extensive bone loss requiring extramedullay replacement of bone. The components of the Comprehensive SRS system have previously been cleared for use in hemi and anatomic total shoulder replacement. The current submission is to expand the indications to include reverse shoulder applications. All components have been previously cleared.

Biomet Comprehensive 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 and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive 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. Titanium glenospheres are intended for patients with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy. Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation. Interlok finish humeral stems are intended for cemented use and the MacroBond coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

This submission is for manufacturing of an alternate version of exiting Comprehensive Standard and Mini Baseplates components with the porous plasma spray (PPS) coating applied by an outside vendor and the addition of Zimmer's Calcicoat coating. There is no change to the design to these existing products. The new Comprehensive Reverse Augmented Baseplate has an augmented backside while retaining the existing Comprehensive Reverse baseplate geometry. The device will be available with three augment sizes, Small, Medium and Large. The new variant will be manufactured with PPS coating applied by a vendor and Zimmer Calcicoat coating.

The ExpressBraid Graft Manipulation is intended for use in soft tissue approximation and/or ligation. The suture may be provided individually or be incorporated as a component, into surgeries where constructs including those with allograft or autograft tissue are used for repair.

The subject device consists of a stainless steel, straight needle attached to a strand of MaxBraid suture. The two ends of the strand of suture are crimped into the needle. The MaxBraid sutures are braided, non-absorbable sutures available in a white configuration consisting of 100% Ultra High Molecular Weight Polvethylene (UHMWPE) fibers and a blue and white co-braid configuration consisting of Deklene II, Polypropylene suture braided into 100% UHMWPE fibers. The suture is provided uncoated. The colorant used in the blue and white co-braid consists of [phthalocyaninato (2-)] copper <0.5% by weight per 21 CFR Sec. 74.3045.