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The AGILON® XO Shoulder Replacement System is indicated for use for total or hemi shoulder replacement in cases of: - · Non- inflammatory deqenerative joint disease including osteoarthritis and avascular necrosis, - · Post-traumatic osteoarthritis. - · Fractures, - · Rheumatoid arthritis. The main indications for the implantation of an AGILON® hemi shoulder prosthesis are: - · Multi-fragmental comminuted fractures of the humeral head, - · 3- and 4-Fragment-fractures of the proximal humerus, - · Head-splitting fractures, - · Dislocated head-splitting fractures, - · Humeral head depression with more than 40% of joint surface depressed, - · Interlocking chronic dislocation with deep HILL-SACHS lesion, - · Fracture instability following internal fixation attempt in 3-fragment fractures (secondary dislocation, material loosening), - · Posttraumatic humeral head necrosis, - · Omarthrosis. AGILON® CTA heads are destined for treatment of stable types of rotator cuff tear arthropathy. In order to achieve satisfactory results with the CTA heads the fornix humeri and the subscapularis tendon must be intact. A CTA cap is intended for the use as a hemi-arthroplasty, to treat a patient after an inverse shoulder has failed. It is not combined with a glenoid implant. It can be used in primary and revision cases. The main indications for the implantation of an AGILON® inverse (reverse) shoulder prosthesis are: - · Rotator cuff tear arthropathy, - · Chronic trauma shoulder, - · Decentering of the humeral head after implantation of a humeral head prosthesis. Please note, that the patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary. In case of revision surgery the available bone stock has to be evaluated to allow for implantation of well-fixed stems. Conversion of the system can be performed in revision cases as follows: - · From Hemi Shoulder Arthroplasty to Anatomic Total Shoulder Arthroplasty - · From Hemi Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty - · From Hemi Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty - · From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi Shoulder Arthroplasty as salvage procedure - · From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty as salvage procedure - From Anatomic Total Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty - · From Anatomic Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty The device is intended for adults. The AGILON® XO Shoulder Replacement System Titanium alloy stems are intended for cementless fixation. The PE-glenoids of the AGILON® XO Shoulder Replacement System are intended for cemented fixation. The qlenoid cementless is intended for cementless use with the addition of screws for fixation.

The AGILON® XO Shoulder Replacement System is a modular shoulder replacement system offering various components that can be combined to replace the shoulder joint with options depending upon the size and anatomical needs of each patient. The subject submission is for new cancellous screws for use in a total reverse shoulder replacement with the previously cleared K231657 components: - Humeral Head Components ● - Glenoid and Glenosphere Components ● - Humeral Stems and Stem Extension Pieces - Metaphyseal Components ● - Fixation and Cancellous Screws ● The subject line extension components are intended for use with previously cleared AGILON XO Shoulder System instruments. There are no changes to packaging, sterility, shelf life, or materials subject to this submission.

The Shoulder Innovation's InSet Total Shoulder System, when used with the Inset Stem, is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following: 1. Significant disability in degenerative, rheumatic disease of the glenohumeral joint; 2. Fractures of the humeral head 3. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. 4. Avascular necrosis of the humeral head 5. Revision where other devices or treatments have failed. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty. The InSet Total Shoulder System components are intended for single use only. The glenoid component is intended for cemented fixation only; the humeral stem may be implanted by press-fit or cement fixation.

The Shoulder Innovations Total Shoulder System consists of modular humeral stems and heads that articulate with a glenoid component. The humeral stems are collarless and manufactured from Titanium Alloy (Ti6-4) with fins to provide rotational stability. The collarless stems allow the humeral head to prevent stem subsidence. The stems have a female Morse-type taper to interface with the modular humeral heads. The proximal body and fins are coated with a rough, porous coating for un-cemented fixation or for use with bone cement. The humeral heads are manufactured from CoCr and are available in standard and offset configurations. The heads have a male Morse-type taper to interface with the humeral stems. The glenoid components of the Total Shoulder System are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The glenoid implant is a peqged design intended for cemented fixation only.

The AGILON® XO Shoulder Replacement System is indicated for use for total or hemi shoulder replacement in cases of: - · Non- inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, - · Post-traumatic osteoarthritis, - · Fractures, - · Rheumatoid arthritis. The main indications for the implantation of an AGILON® hemi shoulder prosthesis are: - · Multifragmental comminuted fractures of the humeral head, - · 3- and 4-Fragment-fractures of the proximal humerus, - · Head-splitting fractures, - · Dislocated head-splitting fractures, - · Humeral head depression with more than 40% of joint surface depressed, - · Interlocking chronic dislocation with deep HILL-SACHS lesion, - Fracture instability following internal fixation attempt in 3-fragment fractures (secondary dislocation, material loosening), - · Posttraumatic humeral head necrosis, - · Omarthrosis. AGILON® CTA heads are destined for treatment of stable types of rotator cuff tear arthropathy. In order to achieve satisfactory results with the CTA heads the fornix humeri and the subscapularis tendon must be intact. A CTA cap is intended for the use as a hemi-arthroplasty, to treat a patient after an inverse shoulder has failed. It is not combined with a glenoid implant. It can be used in primary and revision cases. The main indications for the implantation of an AGILON® inverse (reverse) shoulder prosthesis are: - · Rotator cuff tear arthropathy, - · Chronic trauma shoulder, - · Decentering of the humeral head after implantation of a humeral head prosthesis. Please note, that the patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary. In case of revision surgery, the available bone stock has to be evaluated to allow for implantation of well-fixed stems. Conversion of the system, can be performed in revision cases as follows: - · From Hemi Shoulder Arthroplasty to Anatomic Total Shoulder Arthroplasty - From Hemi Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty - · From Hemi Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty - · From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi Shoulder Arthroplasty as salvage procedure - · From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty as salvage procedure - · From Anatomic Total Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty - From Anatomic Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty The device is intended for adults. The AGILON® XO Shoulder Replacement System Titanium alloy stems are intended for cementless fixation. The PE-glenoids of the AGILON® XO Shoulder Replacement System are intended for cemented fixation. The glenoids cementless are intended for cementless use with the addition of screws for fixation.

The AGILON® XO Shoulder Replacement System is a modular shoulder replacement system offering various components that can be combined to replace the shoulder joint with various options depending upon the size and of each patient. The components can be combined for use in a total (anatomic and reverse) or a hemi shoulder replacement: Hemi Shoulder: - Humeral Head Components (AGILON® XO Cap and AGILON® XO CTA Cap) - Humeral Stems (Cementless) Total Anatomic Shoulder: - Humeral Head Components (AGILON® XO Cap) - Glenoid Components (AGILON® PE-Glenoid, Cemented) - Humeral Stems (Cementless) Total Reverse Shoulder: - Humeral Head Components (AGILON® Cap Inverse and AGILON® PE-Inlay) ● - Glenoid and Glenosphere Components (AGILON® XO Glenoid Baseplate and AGILON® ● Glenosphere) - Humeral Stems (Cementless) Metaphyseal components (including a new line extension 145°), stem extension pieces, and component connection fixation screws are intended to be used for hemi and total (anatomic and reverse) shoulder configurations. The subject system also includes device-specific reusable instruments for use with the subject implants, including an osteotomy guide, implant trials, and a humeral cutting block.

The Comprehensive® Segmental Revision System is intended for use in cases of: - 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. - 2. Revision where other devices or treatments have failed. - 3. Correction of functional deformity. - 4. 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. For the US and Canada only: reverse application is limited to proximal humeral replacement. 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 Augments are not available in all markets.

The Comprehensive Segmental Revision System (SRS) is a multi-piece orthopedic implant designed to replace the humerus up to and including the humeral side of the shoulder and elbow joints. The device is designed specifically for use in cases where there is extensive bone loss requiring extramedullary replacement of bone. The Tissue Attachment Augments provide the option for tissue stabilization and attachment.

The AGILON® XO Shoulder Replacement System is indicated for use for total or hemi shoulder replacement in cases of: - Non- inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, - Post-traumatic osteoarthritis, - Fractures. - Rheumatoid arthritis. The main indications for the implantation of an AGILON® hemi shoulder prosthesis are: - . Multifragmental comminuted fractures of the humeral head. - 3- and 4-Fragment-fractures of the proximal humerus, - Head-splitting fractures. - Dislocated head-splitting fractures, - . Humeral head depression with more than 40% of joint surface depressed, - Interlocking chronic dislocation with deep HILL-SACHS lesion, - . Fracture instability following internal fixation attempt in 3-fragment and 4-fragment fractures (secondary dislocation, material loosening), - Posttraumatic humeral head necrosis, - . Omarthrosis. AGILON® CTA heads are destined for treatment of stable types of rotator cuff tear arthropathy. In order to achieve satisfactory results with the CTA heads the fornix humeri and the subscapularis tendon must be intact. A CTA cap is intended for the use as a hemi-arthroplasty to treat a patient in revision cases after an inverse shoulder has failed. It is not combined with a glenoid implant. It can also be used in primary cases. The main indications for the implantation of an AGILON® inverse (reverse) shoulder prosthesis are: - Rotator cuff tear arthropathy, - Chronic trauma shoulder, - Decentering of the humeral head after implantation of a humeral head prosthesis. Please note, that the patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary. AGILON® retentive caps invers are indicated in case of shoulder joint instability if the joint cannot be stabilized with a regular AGILON® cap inverse in combination with a Glenosphere. Warning: The use of the AGILON® retentive caps invers entails a decrease of the Range of Motion of the prosthesis. The surgeon has to balance conscientiously the advantage of stabilization and the increased risk of scapula impingement. In case of revision surgery the available bone stock has to be evaluated to allow for implantation of well-fixed stems. Conversion of the system can be performed in revision cases as follows: - . From Hemi Shoulder Arthroplasty to Anatomic Total Shoulder Arthroplasty - From Hemi Shoulder Arthroplasty to Hemi CTA . Shoulder Arthroplasty - From Hemi Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty - From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi Shoulder Arthroplasty as salvage procedure - . From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty as salvage procedure - From Anatomic Total Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty - From Anatomic Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty The surgeon decides which version of prosthesis for the individual patient is used. This decision depends on several factors, such as the age and the patient's weight, bone quality, shape of the bone and deformation of the joint. The device is intended for adults. The stems of the AGILON® XO Shoulder Replacement System are intended for cementless fixation. The glenoids of the AGILON® XO Shoulder Replacement System are intended for cemented fixation.

The purpose of this Traditional 510(k) is introduce into interstate commerce in the United States the ALIGON® XO Glenoid Cemented components to the AGILON XO Shoulder System. The components are a line extension to the previously cleared AGILON XO Shoulder Replacement System which add all polyethylene cemented glenoids to the current system. The components introduced with this submission are intended to mate with other previously cleared implantcast shoulder components to make a complete prosthesis.

General indications: The LINK Embrace Shoulder System - Anatomic Configuration is intended for anatomic total or hemi shoulder arthroplasty. Indications: • A severely painful and/or disabled shoulder joint resulting from osteoarthritis or theumatoid arthritis - · Avascular necrosis of the humeral head - · Deformity and/or limited motion · Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory · Revision of a failed primary component - · Ununited humeral head fractures - · Cuff tear arthropathy (CTA Heads only) The All Poly Glenoid Components are intended for cemented use. The Humeral Stems Standard with CaP (HX) and Short with CaP (HX) are intended for cementless fixation. The Humeral Stems Standard without CaP (HX) and Short without CaP (HX) are intended for cementless fixation. The Humeral Fracture Stems are intended for cementless fixation.

The LINK Embrace Shoulder System offers diverse fixation options suitable for the majority of patient populations and indications. A wide range of stems in different configurations allows for cemented and cementless fixation. Humeral Stems (Ti6Al4V) are available in monoblock designs, and feature a proximal modular taper connection for assembly to head adapters. The monoblock Humeral Stems are available in Standard Stems and Short Stems with a broad size spectrum, and in non-coated and Calcium Phosphate coated versions. Humeral Fracture Stems are also available. The Humeral Stems have been previously cleared for use with the LINK Embrace Shoulder System – Reverse [K200368]. Humeral Heads (CoCrMo) are available in several sizes with a female taper for connection to the Head Adapters. CTA Heads (CoCrMo) are available in neutral and different offset versions and feature a male taper for connection to Humeral Stems. The Cemented All Poly Glenoids are available in conventional polyethylene and in highly crosslinked polyethylene with Vitamin E (E-Dur). The LINK Embrace Shoulder System is supported by a streamlined, lightweight and ergonomic instrument set.

When used in the Humelock II Cemented Shoulder System: The Humelock II Cemented Shoulder System is indicated for use in total and hemishoulder replacement to treat: 1. Proximal humeral fractures 2. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis; 3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail). The humeral stem and glenoid components of the Humelock II Cemented Shoulder System are intended for cemented use only. TiN coated Heads are not intended for hemi-shoulder arthroplasty When used with the Humeris™ Shoulder System: In an anatomic shoulder configuration, the Humeris Shoulder System is indicated for use in total and hemi-shoulder replacement to treat: - A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis; - Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail). TiN coated Heads are not intended for hemi-shoulder arthroplasty. In a reverse shoulder configuration, the Humeris Shoulder is indicated for primary or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear. The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The humeral stem of the Humeris Cementless Shoulder is intended for cementless use only. The humeral stem of the Humeris Cemented Shoulder is intended for cemented use only. The glenoid components of the Humeris Shoulder System are intended for cemented use only. The glenoid baseplate component is intended for cementless use with the addition of screws for fixation.

The TiN Coated Humeral Head is a new component for Humelock II total shoulder replacement systems. The TiN Coated Humeral Head has a titanium nitride (TiN) coating, which is applied to the predicate humeral heads made of cobalt chromium molybdenum (CoCr). Compatible components for use with the TiN coated humeral heads to complete the total shoulder replacement construct are the same as those previously cleared compatible components for use with the CoCr humeral heads in the respective predicate devices, including the primary predicate (K123814) and K163669 for the Humeris Shoulder System.

The Shoulder Innovations Total Shoulder System is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following: 1. significant disability in degenerative, rheumatic disease of the glenohumeral joint; 2. avascular necrosis of the humeral head. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty. The Total Shoulder System components are intended for single use only. The glenoid component is intended for cemented fixation only; the humeral stem may be implanted by press-fit or cement fixation.

The Shoulder Innovations Total Shoulder System consists of modular humeral stems and heads that articulate with a glenoid component. The humeral stems are collarless and manufactured from Titanium Alloy (Ti6-4) with fins to provide rotational stability. The collarless stems allow the humeral head to prevent stem subsidence. The stems have a female Morse-type taper to interface with the modular humeral heads. The proximal body and fins are coated with a rough, porous coating for un-cemented fixation or for use with bone cement. The humeral heads are manufactured from CoCr and are available in standard and offset configurations. The heads have a male Morse-type taper to interface with the humeral stems. The glenoid components of the Total Shoulder System are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The glenoid implant is a multi-pegged design intended for cemented fixation only.

The Catalyst CSR Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where hemi- or total shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment. The Catalyst CSR Shoulder System is intended for use in patients with the following conditions where the humeral head, neck and glenoid vault are of sufficient bone stock and the rotator cuff is intact or reconstructable. - Osteoarthritis - Avascular Necrosis - Rheumatoid Arthritis - Post-traumatic Arthritis - Correction of functional deformity The Catalyst CSR humeral and glenoid implants are intended for cemented use. The Catalyst CSR Press-Fit humeral implants are intended for uncemented or cemented use.

The Catalyst CSR Shoulder System is a bone preserving total shoulder prosthesis designed for use in patients where the humeral head, neck and glenoid vault are of sufficient bone stock and there is an intact or reconstructable rotator cuff. The design requires minimal bone resection, thus giving the patient an alternative to other total shoulder designs where more bone is removed. This submission adds augmented glenoid components to the CSR Shoulder System. The CSR Augmented Glenoids are nearly identical to the previously cleared CSR 3 Peg Glenoids, except that additional material has been added to the fixation surface creating a 10 degree posterior wedge. Like the previously cleared CSR 3 Peg glenoid components, the CSR Augments are manufactured from UHMWPE conforming to ASTM F648. Also like the previously cleared CSR 3 Peg Glenoid components, three sizes of augmented glenoid components are available. The bearing surface has a symmetrical, oval shaped profile allowing use of each component on either the right or the left side. The glenoid component is designed to allow insertion at an angle, in the same orientation as the surgeon's exposure, to reduce the forceful retraction and bone and soft tissue trauma usually required to insert standard glenoid components. Three backside pegs are engineered to provide implant fixation within the dense cortical and subchondral bone. The CSR Augmented Glenoid components are compatible with previously cleared CSR Press-Fit humeral components.

The Signature™ ONE System is indicated, based on patient-specific radiological images with identifiable placement anatomical landmarks, to assist in pre-operative planning and/or intra-operative guiding of surgical instruments for shoulder replacement surgical procedures on patients not precluded from being radiologically scanned. The Signature™ ONE System is to be used with the glenoid components of the following shoulder implant systems in accordance with their indications: Zimmer® Trabecular Metal™ Reverse Plus Shoulder, Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System and Comprehensive® Reverse Augmented Baseplates. The Signature™ ONE Guides and bone models are intended for single use only.

The Signature™ ONE System is developed to assist in pre-operative planning of the glenoid component for Total Shoulder Arthroplasty (using the Signature™ ONE Planner) and to accurately transfer a pre-operative plan to orthopedic surgical procedures (using the Signature™ ONE Guides) if desired. Both anatomic and reverse (TSA and RSA respectively) approaches are supported. The Signature ONE Guides and Bone Model are designed and manufactured of polyamide (nylon) using additive manufacturing (selective laser sintering), based on the approved/finalized pre-surgical plan and shipped prior to surgery. The guides and bone models are provide nonsterile and sterilized at the hospital. They are used intraoperatively to assist the surgeon in reproducing the plan. The Signature ONE System surgical technique remains close to the conventional shoulder arthroplasty to allow converting to standard surgical technique at any time if needed during the operation. The Signature™ ONE System uses the Zimmer Biomet Drive Portal for the interaction with external users (i.e. imaging technician and the surgeon). The internal users (i.e. the Zimmer Biomet operators) use manufacturing software applications to prepare the patient cases for the surgeon.