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TEMA Elbow System is intended for use in cemented applications for patients suffering from disability due to: - 1. Elbow joint destruction which significantly compromises the activities of daily living - 2. Non-Inflammatory degenerative joint disease including osteoarthritis, and avascular necrosis with hemophilia. - 3. Rheumatoid arthritis or degenerative arthritis with incapacitating pain - 4. Revision where other devices or treatments have failed. - 5. Correction of severe functional deformity. - 6. Treatment of acute or chronic fractures with distal humerus epicondyle involvement. - 7. Post-traumatic lesions or bone loss contributing to elbow instability or loss of motion The unlinked, semi-constrained version is intended for use in cases where there are functioning medial and lateral elbow ligaments of good quality that provide immediate stability, resisting any tendency of dislocation or disengagement between ulnar and humeral components, when intraoperative manual testing is performed.

TEMA Elbow System is a cemented total elbow prosthesis. The system provides both linked (constrained) and unlinked (semi-constrained) configurations. TEMA Elbow System consists of modular humeral and ulnar assemblies. The humeral assembly consists of a metallic humeral stem and a metallic humeral body component with pre-assembled polyethylene bushings. The ulnar assembly is composed of a metallic ulnar stem, a metallic ulnar body and a polyethylene ulnar liner. Screws are used to secure the taper couplings between the stems and bodies of the humeral and ulnar assemblies. The constrained (linked) version of the elbow consists of the modular humeral assembly and the modular ulnar assembly with an axle component that is inserted across the joint to connect the humeral assembly to the ulnar assembly. The semi-constrained (unlinked) version consists of the same components without the use of the axle to link the humeral and ulnar assemblies. All of the system components are available in different sizes. The modularity of the polyethylene ulnar component also allows replacement of the ulnar bearing, if needed, without removal of the humeral and ulnar assemblies. The modularity also provides an additional advantage that if replacement of the humeral and/or ulnar body is needed (e.g. due to damage from a traumatic event or due to excessive wear of the bushing of the humeral body) and the stem components are well fixed. the stems do not need to be removed and only disconnection of the humeral and ulnar bodies from the stems is required for their revision.

Coonrad/Morrey Total Elbow: Indications include: post-traumatic lesions or bone loss contributing to elbow instability; ankylosed joints, especially in cases of bilateral ankylosis from causes other than sepsis; advanced rheumatoid or degenerative arthritis with incapacitating pain: revision arthroplasty, and instability or loss of motion when the degree of joint damage precludes less radical procedures. The candidate for total elbow arthroplasty should exhibit joint destruction which significantly compromises the activities of daily living. Patient with single joint involvement (generally those with traumatic or degenerative arthritis) or significant lower extremity disability which require walking aids are less amenable to treatment than patients with advanced and predominantly upper extremity involvement. If possible, elbow replacement should be done after hip or knee surgery to avoid excessive stress to the prosthesis required by crutch walking during total hip or knee rehabilitation. Zimmer Nexel Total Elbow: Indications for use include: Elbow joint destruction which significantly compromises the activities of daily living; Post-traumatic lesions or bone loss contributing to elbow instability; Ankylosed joints, especially in cases of bilateral ankylosis from causes other than active sepsis; Advanced rheumatoid, post-traumatic, or degenerative arthritis with incapacitating pain; Instability or loss of motion when the degree of joint or soft tissue damage precludes reliable osteosynthesis; Acute comminuted articular fracture of the elbow joint surfaces that precludes less radical procedures, including 13-C3 fractures of the distal humerus; Revision arthroplasty. Caution: This device is intended for cemented use only.

The Coonrad/Morrey Total Elbow and Zimmer Nexel Total Elbow are total elbow prosthesis designed for use with bone cement. They are available in multiple sizes and in right and left configurations. The devices are designed to replace the articulating surfaces of and restore motion to the humeroulnar (elbow) joint. The implants are constrained in design and consist of a humeral component and an ulna component joined through bearings in a hinged fashion. The purpose of this submission is the addition of MR conditional language to the labeling for these products. The addition of MR labeling to the subject devices does not impact indications, materials, design features or dimensions of the components, compatibility, packaging or sterilization. Additionally, this submission includes minor modifications to the subject device systems.

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. 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 and total humeral applications. Tissue Attachment Augments provide the option for tissue stabilization and attachment.

The components of the Comprehensive Segmental Revision System (SRS) components may be combined to create a proximal humeral replacement, distal humeral replacement and total humeral replacement. Previously cleared for use in conjunction with Biomet's Discovery Elbow System, the Comprehensive SRS system is being expanded to be compatible with the Zimmer Nexel Total Elbow. To accomplish this, the only component requiring modification is the Distal Humeral Body. The modified distal humeral bodies will be available in left and right configurations in three sizes 50, 60 and 70mm utilizing the same modular flange as the predicate device. The yoke geometry will match that of the humeral component in the Nexel Total Elbow System.

Indications for use include: - Elbow joint destruction which significantly compromises the activities of daily living - Post-traumatic lesions or bone loss contributing to elbow instability - Ankylosed joints, especially in cases of bilateral ankylosis from causes other than active sepsis - Advanced rheumatoid, post-traumatic, or degenerative arthritis with incapacitating pain - Instability or loss of motion when the degree of joint or soft tissue damage precludes reliable osteosynthesis - Acute comminuted articular fracture of the elbow joint surfaces that precludes less radical procedures, including 13-C3 fractures of the distal humerus - Revision arthroplasty CAUTION: This device is intended for cemented use only.

The Zimmer Nexel Total Elbow system includes a cemented total elbow prosthesis and instrumentation. No changes are being made to the implants, but two changes to the instrumentation are being proposed in this submission. • The Zimmer Nexel Total Elbow surgical technique is being modified to include a back table utilization of the Ulnar Bearing Assembly Tool (UBAT). • As a result of the surgical technique change, the subject Zimmer Nexel Total Elbow Ulnar Cement Diverter is being added as an accessory instrument to the existing Zimmer Nexel Total Elbow system. The proposed cement diverter is a sterile, single-use manual orthopedic instrument manufactured from Ultra High Molecular Weight Polyethylene in conformance with ASTM F648-14. The subject component diverts excess bone cement from the articular surfaces of the existing ulnar implant component during implantation.

Indications for use include: - Elbow joint destruction which significantly compromises the activities of daily living ー - Post-traumatic lesions or bone loss contributing to elbow instability - - Ankylosed joints, especially in cases of bilateral ankylosis from causes other than active sepsis - - Advanced rheumatoid, post-traumatic, or degenerative arthritis with incapacitating pain - - Instability or loss of motion when the degree of joint or soft tissue damage precludes reliable osteosynthesis - Acute comminuted articular fracture of the elbow joint surfaces that precludes less radical procedures, including 13-C3 fractures of the distal humerus - Revision arthroplasty Caution: This device is intended for cemented use only.

The Zimmer Nexel total Elbow is a total elbow prosthesis designed for use with bone cement. It is available in multiple sizes and in right and left configurations. How the Device Functions: The Zimmer Nexel Total Elbow is an implant designed to replace the articulating surfaces of and restore motion to the humeroulnar (elbow) joint. The implant is a constrained device assembly and consists of the following components: humeral component, ulnar component, humeral bearing-A, ulnar bearings-B, axle pin and humeral screws. The Following Scientific Concepts, Design Features and Physical Properties form the Basis for the Zimmer Nexel Total Elbow: The humeral component has a humeral stem designed to be implanted with bone cement into the patient's humeral medullary canal, an anterior flange designed to accept a bone graft and limit torsional and posterior migration, a humeral yoke with rounded corners to avoid the creation of stress risers within the medial and lateral humeral supracondylar columns, and plasma spray region to enhance fixation to bone cement within the medullary canal, and to improve fatigue strength. The ulnar component has an ulnar stem designed to be implanted with bone cement into the patient's ulnar medullary canal, an ulnar eye that is both highly polished and nitrogen-enriched to limit wear of the apposing polymer bearings, and plasma spray region to enhance fixation to bone cement within the medullary canal. Bearings A and B are designed to broadly distribute joint reaction forces. Materials Used: The humeral and ulnar components are made of a titanium alloy, the bearings A and B are made of Vitamin E highly cross-linked polyethylene, and the humeral screws and axle pin are made of a cobalt-chromium-molybdenum alloy.

The Discovery Elbow - X-Small is intended for cemented use in patients with the following conditions: 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. Treatment of acute or chronic fractures with humeral epicondyle involvement, which are unmanageable using other treatment methods

The Discovery™ Elbow is a total elbow prosthesis comprised of an ulnar and humeral component. Placing the humeral articulation through the ulnar articulation links the ulnar and humeral component. The humeral components are available with or without a flange. The numeral and ulnar components are avialalbe with either a smooth or roughened surface. The components contained in this submission are X-Small in size.

The Acclaim™ Total Elbow System is indicated to reduce pain and improve the function and mobility of the affected joint in patients with a painful arthritic joint due to osteoarthritis, theumatoid arthritis, or post traumatic arthritis and pathological fractures of the distal humerus in which adequate bone stock exists for the fixation of prosthetic components. Total Elbow replacement may be considered for younger patients, if, in the opinion of the surgeon, an unequivocal indication for elbow replacement outweighs the risks associated with the age of the patient , and if limited demands regarding activity and elbow joint loading can be assured. This included patients for whom an immediate gain of elbow mobility may lead to an expectation of significant improvement in the quality of their lives. The Acclaim™ Total Elbow System is intended for cemented use only.

The Acclaim™ Total Elbow System replacement hinge pin assembly is designed as a replacement of a linked (constrained) elbow hinge pin assembly due to hinge pin disassociation. When the Acclaim Total Elbow System is implanted as a linked system. it is held together with the linked ulnar component and pin assembly, and is used when there is poor bone stock. The Acclaim™ Total Elbow System replacement hinge pin assembly is comprised of a polyethylene humeral yoke and locking sleeve, with a metal locking pin, ulnar bearing, ulnar bearing screw, washer, and wire. The replacement hinge pin assembly is used in conjunction with well-fixed humeral and ulnar components. Acclaim™ Total Elbow System replacement hinge pin assembly design includes modifications to the ulnar bearing, polyethylene sleeve, and locking pin. In addition, a washer and cross-pin locking mechanism has been included to the assembly using the same design as the Mark II Total Elbow System locking mechanism, previously cleared in K872084 dated June 25, 1987.

Indications include: post-traumatic lesions or bone loss contributing to elbow instability; ankylosed joints, especially in cases of bilateral ankylosis from causes other than sepsis; advanced rheumatoid or degenerative arthritis with incapacitating pain; revision arthroplasty, and instability or loss of motion when the degree of joint damage precludes less radical procedures. The candidate for total elbow arthroplasty should exhibit joint destruction which significantly compromises the activities of daily living. Patient with single joint involvement (generally those with traumatic or degenerative arthritis) or significant lower extremity disability which require walking aids are less amenable to treatment than patients with advanced and predominantly upper extremity involvement. If possible, elbow replacement should be done after hip or knee surgery to avoid excessive stress to the prosthesis required by crutch walking during total hip or knee rehabilitation.

The Coonrad Morrey Total Elbow is a total elbow prosthesis designed for use with bone cement. It is available in regular, small and extra small sizes, in right and left configurations.

The Porous Coated Discovery™ Elbow is intended for cemented use in patients with the following conditions: 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 severe functional deformity. 5. Treatment of acute or chronic fractures with humeral epicondyle involvement, which are unmanageable using other treatments.

The Porous Coated Discovery™ Elbow is a total elbow prosthesis comprised of an unfidrar components of components. The humeral components. The humeral through the unfar anticulation into the une and ulnar components are porous coated to provide enhanced fixation.

The LPS Upper Extremity is intended for use in replacement of the proximal, mid-shaft or intercalary portion, distal and/or total humerus. This system is especially designed for cases that require extensive resection and restoration. Specific diagnostic indications for use include: - Primary bone neoplasnms (e.g., osteosarcomas, chondrosarcomas, Ewing's sarcomas) requiring extensive resection(s) and replacement(s) of the proximal and/or distal humerus; - Metastatic bone disease and pathologic fractures with extensive bone loss or where other forms of treatment such as internal fixation are inadequate; - Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (JD), e.g., rheumatoid arthritis, requiring extensive resection and replacement of the proximal and/or distal humerus; - Patients suffering from congential or acquired deformity, such as post-traumatic deformity and/or arthritis; - Communited fractures of the proximal, distal and/or humeral shaft where forms of fixation are indadequate; - Persistent humeral fracture non-union; - Patients suffering from severe cuff tear arthropathy that does not respond to any conservative therapy or better alternative surgical treatment; - Revision shoulder or elbow arthroplasty cases requiring extensive resection(s) and replacements of the proximal, distal or total humerus. - Severe trauma requiring extensive resection and replacement. The LPS Upper Extremity components are for CEMENTED USE ONLY.

The LPS Upper Extremity components are designed for the replacement of the mid-shaft or intercalary portion of the humerus, proximal, distal and/or total humerus. Unlike primary shoulder and elbow systems, this system is used when the amount of resection and restoration is extreme (e.g. in oncology cases, end-stage revision). A total humeral replacement is possible in those cases where no part of the humerus can be salvaged.