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The restor3d rTSA System 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. The restor3d rTSA System 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 component with porous surface is indicated for uncemented biological fixation application only. The restor3d rTSA System glenoid baseplate components are intended for cementless application with the addition of screw fixation. Humeral components with porous surface are indicated for either cemented or uncemented applications.

The restor3d Reverse Total Shoulder Arthroplasty System is intended for patients requiring a reverse shoulder replacement for patients with a functional deltoid muscle and with a deficient rotator cuff. The restor3d Reverse Total Shoulder Arthroplasty System consists of the glenoid baseplate, glenosphere intraoperatively affixed to the baseplate, humeral stem, and polymer bearing component affixed to the humeral stem. Additionally, the system includes supporting standard instrument trays and all required accessories (e.g., security screws, peripheral screws).

AltiVate Reverse® Shoulder System, Reverse® Shoulder Prosthesis (RSP®), SMR Shoulder System, PRIMA Humeral System, and PRIMA Glenoid System are intended for various forms of partial or total, primary or revision shoulder joint replacement. Specific indications depend on the system and configuration (modular, monoblock, anatomic, reverse), addressing conditions such as: - Grossly rotator cuff deficient shoulder joint with severe arthropathy - Previously failed joint replacement with a grossly rotator cuff deficient shoulder joint - Functional deltoid muscle is necessary to use the device - Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder (including humeral head fracture or displaced 3- or 4-part fractures of proximal humerus) - Bone defect in proximal humerus - Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid - Inflammatory arthritis including rheumatoid arthritis - Correction of functional deformity - Treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods - Revision of a failed primary implant (if sufficient bone stock remains) - Cuff tear arthropathy (CTA Heads only) - Glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid Glenoid only) - Massive irreparable rotator cuff tear The patient's joint must be anatomically and structurally suited to receive the selected implant(s). Some components are intended for cemented and/or cementless application, often with the addition of screws for fixation. Revision surgery can include conversion from anatomic to reverse arthroplasty if the stem is stable, well positioned, and tissue integrated.

This 510(k) submission proposes updated labeling to reflect additional compatibility between previously cleared shoulder systems from Encore Medical, L.P. (AltiVate Reverse® Shoulder System) and LimaCorporate S.p.A. (SMR and PRIMA Shoulder Systems). The update allows for cross-system use of humeral and glenoid components for reverse total shoulder arthroplasty, where compatible sizes exist. There are no changes to the design, materials, function, or intended use of the devices, and no new implants or instruments are introduced. The proposed configurations include using an AltiVate Reverse® humeral stem and insert with SMR or PRIMA glenoid components, and vice versa.

The Jarvis Glenoid Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a 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 glenoid baseplate is intended for cementless application with the addition of screws for fixation.

The JARVIS Glenoid Reverse Shoulder Prosthesis is used for reverse shoulder prosthesis, intendedfor primary, fracture or revision shoulder replacement. The JARVIS Glenoid Reverse Shoulder Prosthesis is made up of three components - glenophere, baseplate, and fixation component (screw or post) . All components are offered in varying sizes to accommodate patient anatomy. The baseplate and screw components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3, while the glenophere is manufactured from wrought cobalt chromium molybdenum alloy per ASTM F1537/ISO 5832-12. All components are provided sterile via gamma irradiation.

The BLUEPRINT™ Glenoid Guides are patient-specific drill guides. They have been specially designed to assist in the intraoperative positioning of glenoid components used with total anatomic or reversed shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans. Blueprint® is a medical device for surgeons. Blueprint® is intended to be used as a pre-surgical planner for shoulder replacement surgery. Blueprint® requires CT scan images showing the anatomical shoulder structure in a DICOM format. Blueprint® allows surgeons to visualize, measure, reconstruct, and annotate anatomic data. Blueprint® allows surgeons to design patient specific components (patient-specific instruments and Shoulder iD™ Primary Reversed Glenoid*) based on the pre-surgical plan. Blueprint® leads to the generation of a planning report. Blueprint® is to be used for adult men and women patients only whose bone maturity is reached and should not be used for diagnostic purpose. Note: Measures and patient specific guide design are provided depending on the case profiles. *Only if patient-specific instruments or Shoulder iD™ Primary Reversed Glenoid are available in your geography. The Shoulder iD™ Primary Reversed Glenoid implant is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by: · Rheumatoid arthritis - · Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) - · Correction of functional deformity - · Fractures of the humeral head - · Traumatic arthritis - · Revision of glenohumeral joint if sufficient native glenoid bone remains All components are single use. The Shoulder iD™ Primary Reversed Glenoid implant is anchored to the bone with screws and is for non-cemented fixation. Note: A CT Scan is used to create the Shoulder iD™ Primary Reversed Glenoid implant

BLUEPRINT™ Patient Specific Instrumentation Blueprint Patient Specific Instrumentation is composed of two components: Blueprint Glenoid Guides (hardware) and Blueprint Planning Software (software) Blueprint™ Glenoid Guides The Blueprint Glenoid Guides are patients specially designed to facilitate the implantation of Wright-Tornier glenoid prostheses. The Blueprint Glenoid Guides are designed and manufactured based on a pre-operated only by the software Blueprint Planning Software. Blueprint™ Planning Software Blueprint Planning Software is a software connected to an Online Management System (OMS). The user interface software is installed on a computer and is intended to be used by orthopedic surgeons, as a preoperative planning software for shoulder arthroplasty surgery (anatomic and reversed). It is intended to help to plan an operation by allowing surgeons to: - · Plan for shoulder arthroplasty cases - · Position and select glenoid and humeral implants, - · Simulate the prosthetic range of motion, - · Interact with implants and different computed measurements - · Generate information required to design a patient-specific glenoid component when appropriate. Shoulder iD™ Primary Reversed Glenoid The Shoulder iD Primary Reversed Glenoid implant (Shoulder iD) is intended to replace the native glenoid surface of the scapulohumeral joint as part of a reverse shoulder prosthesis. The glenoid implant is composed of a baseplate with a press-fit post, peripheral anchoring screws, and a glenosphere. Ancillary instruments are also provided for the implantation of the prosthesis.

The Equinoxe Shoulder System is indicated for use individuals with degenerative diseases or fractures of the glenolumeral joint where total or hemi-arthroplasty is determined by the preferred method of treatment. - The cemented primary humeral stem, longrevision stems, and all Equinoxe glenoids are intended for cemented fixation. - The press-fit humeral stems are intended for press-fit applications but may be used with bone cement at the surgeon. - . The reverse humeral components are intended to be used in cemented applications or in revision cases when the humeral component is well-fixed/stable, as deemed by the orthopaedic surgeon. - . Humeral Heads are intended for use in cemented and press-fit applications. Clinical indications for the PRIMARY (P), LONG/REVISION (L), and FRACTURE (F) humeral components are as follows: - Rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative problems - Congenital abnormalities in the skeletally mature - Primary and secondary necrosis of the humeral head. - Humeral head fracture with displacement of the tuberosities - Pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable - Revisions of humeral prostheses when other treatments or devices have failed (where adequate fixation can be achieved) - Displaced three-part and four-part upper humeral fractures - Spiral and other fractures of the mid-humerus (in combination with glenohumeral degenerative diseases) - Revision of failed previous reconstructions when distal anchorage is required - To restore mobility from previous procedures (e.g. previous fusion) The Equinoxe Reverse Shoulder System is in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe Reverse Shoulder is also indicated for a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head. The Equinoxe Platform Fracture Stem is in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4-part fractures (hemi-athroplasty), or acute fracture of the proximal humerus with failure of the glenohumeral joint (primary total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is also indicated for acute fracture of the proximation with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superil head (reverse total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is indicated for cemented use only.

The Central Screw Baseplate System is comprised of devices that will be included as part of the Exactech Equinoxe® Shoulder System for reverse total shoulder arthroplasty (rTSA). The Central Screw Baseplate System includes Glenoid Baseplates, Central Compression Screws, a Locking Plate, a Locking Nut, and a Glenosphere Locking Screw. Previously cleared components used with the Central Screw Baseplate System include Peripheral Screws and Glenoid components. The design of the proposed Central Screw Baseplate System is based on the existing foundation and principles of the currently marketed Equinoxe Standard and Small Reverse Baseplates.

The AltiVate Reverse® Shoulder Prosthesis is indicated as a reverse shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to: Severe arthropathy with a grossly deficient rotator cuff; Previously failed joint replacement with a grossly deficient rotator cuff; Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection; Bone defect in proximal humerus; Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid; Inflammatory arthritis including rheumatoid arthritis; Correction of functional deformity. The glenoid baseplate is intended for cementless application with addition of screws for fixation. This device may also be indicated in the salvage of previously failed surgical attempts for anatomic and hemi procedures. All RSP® Monoblock and AltiVate Reverse® humeral stems are intended for cemented or cementless use.

The AltiVate Reverse® Glenoid is a line extension to the existing RSP Glenoid System consisting of additional size offerings, modularity, and augment/revision offerings for varying glenoid morphologies for use in reverse Total Shoulder Arthroplasty (TSA) applications. The new implants consist of modular neutral and augmented baseplates, Torx peripheral screws, porous coated pegs, and additional offsets of glenospheres. All of the subject device implants are manufactured from Ti-6Al-4V except the glenospheres, which are manufactured from CoCrMo. New device specific accessories/instruments have been developed and are intended to facilitate proper implantation of the glenoid shoulder system.

When used in the Humelock II Reversible Shoulder System: The Humelock II Reversible Shoulder is indicated for primary, fracture 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 stems are intended for cemented or cementless use. The metaglene baseplate is intended for cementless use with the addition of screws for fixation. When used in the Humelock Reversed Shoulder System: The Humelock Reversed Shoulder is indicated for primary, fracture or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable cuff tear. The patient's joint must be anatomically suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. During primary or revision surgery, if the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or the glenoid bone fractures during the procedure, a taper adapter can be used to convert the Humelock Reversed Shoulder to an anatomic hemi-shoulder prosthesis. The humeral stem of the Humelock Reversed Cemented Shoulder Prosthesis is intended for cemented use only. The humeral stem of the Humelock Reversed Cementless Shoulder Prosthesis is lockable with two cortical bone screws and is intended for cementless or cemented stems. The glenoid baseplate and post extension are intended for cementless use with the addition of screws for fixation. When used in the Humeris Shoulder System and Humeris 135 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). 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 baseplate component is intended for cementless use with addition of screws for fixation. When used in the FX V135 Shoulder Prosthesis: In an anatomic shoulder configuration, the FX V135 Shoulder Prosthesis 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). In a reverse shoulder configuration, the FX V135 Shoulder Prosthesis 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 FX V135 Cementless Shoulder is intended for cementless use only, with optional cortical bone screws for the longer stems. The glenoid components of the FX V135 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 Full Wedge Lateralized and Augmented Baseplates are new components added to the reverse shoulder replacement systems including the Humelock II Reversible Shoulder System, the Reversed (K162455), the Humeris Shoulder (K163669, K222936) and the FX V135 Shoulder Prosthesis (K213117, K223801). The Lateralized baseplate with full wedge augmentation is a modification of the primary predicate half wedge lateralized and augmented baseplates (K210790) and may be used with an asymmetric bone defect when there is no possibility to correct this defect without graft or excessive reaming. Compatible components for use with the Full Wedge Lateralized and Augmented Baseplates are the same as the compatible components for use in the previously cleared reverse shoulder replacement systems.

The Augment Off-Axis Instrument System consists of specialized instruments intended to prepare anatomy prior to implantation of Comprehensive® Reverse Shoulder System components in reverse total shoulder arthroplasty procedures or Alliance® Augmented Glenoid System components in anatomic total shoulder arthroplasty procedures in accordance with their respective cleared indications for use and contraindications. The instruments for this system are specifically indicated for use with the Comprehensive ® Reverse Shoulder System (K193373) or the Alliance® Augmented Glenoid System (K193180).

The Augment Off-Axis Instrument System consists of specialized instruments that are designed for preparation of anatomy prior to implantation of Comprehensive® Reverse Shoulder System or Alliance® Augmented Glenoid System components. The instruments in this system are intended to provide an alternate approach in ensuring proper preparation of the glenoid bone and tissue for receipt of a glenoid implant augment in reverse and anatomic total shoulder arthroplasty procedures. A drop-in instrument tray contains the Augment Off-Axis reusable surgical instruments for secure and ergonomic storage, sterilization, and transportation between uses.

The Catalyst F1x Shoulder System is a reverse total shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to: · Severe arthropathy with a grossly deficient rotator cuff; · Previously failed joint replacement with a grossly deficient rotator cuff; · Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection; • Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural head and/or glenoid; · Inflammatory arthritis including rheumatoid arthritis; · Correction of functional deformity The Catalyst F1x press-fit stems are intended for cementless press-fit applications. The Catalyst F1x cemented stems are intended for cemented fixation. The Catalyst F1x stem is compatible with the implants from the R1 Shoulder Systems.

The Catalyst F1x Shoulder System is intended for use as a replacement of shoulder joints in reverse arthroplasty. The stems can be used in conjunction with the Catalyst R1 Reverse Shoulder humeral articulating poly inserts and glenoid implants for use in reverse shoulder arthroplasty. This submission for the Catalyst F1x Shoulder System consists of proximal bodies, distal stems, locking screws and spacers. The fracture specific proximal bodies have asymmetric, right- and left-sided finned geometry to provide specific locations to reattach the greater and lesser tuberosities for a stable reconstruction of the proximal humerus. The proximal bodies have a porous titanium structure on the bone engaging regions. The distal stems shall be provided in varying diameters to accommodate varying bone geometries. The distal stems will be offered in press-fit and cemented versions. The press-fit distal stems shall have a tapered, splined proximal geometry with an HA (hydroxyapatite) coating. The cemented stems shall have a smooth stem geometry. The proximal bodies and distal stems shall be secured together using a mechanical taper interface that is supplemented with a locking screw. Spacers shall be provided to offer additional options for restoring the appropriate humeral height.