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The MyShoulder Planner software is a medical device intended for use by surgeons as a preoperative planning tool for total shoulder replacement surgery in skeletally mature individuals. The MyShoulder Planner software is specifically designed to support the planning of the humeral and glenoid components in a total shoulder replacement using Medacta Shoulder System prosthesis. The MyShoulder Planner software should not be used for diagnostic purposes. The MyShoulder Planner software processes CT scan images in DICOM format to allow surgeons to visualize, measure, and reconstruct anatomic data. These features enable surgeons to make decisions on implant size and positioning, including the ability to annotate anatomical structures. The MyShoulder Planner software leads to the generation of patient-specific planning reports, which summarize the preliminary decisions regarding implant size and positioning. The MyShoulder Planner software allows the surgeons to request the MyShoulder patient matched guides according to the pre-surgical plan.

The MyShoulder Planner is a software designed to create patient-specific preoperative plans based on CT scans. It is used to visualize the effect of different devices and positioning options on the patient's shoulder joint biomechanics. It allows the surgeon to preoperatively plan the humeral and glenoid components in total shoulder replacement after the segmentation of a 3D model of the patient's anatomy that can be performed automatically by the software, which uses machine learning algorithms, or manually by a designated Medacta engineer.

Tornier Humeral Reconstruction System (Tornier HRS) IN ANATOMIC: The Tornier HRS is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain. The Tomier HRS is indicated for use as a replacement of shoulder joints disabled by: - · Rheumatoid arthritis with pain - · Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) - · Correction of functional deformity - · Fractures of the humeral head - · Traumatic arthritis - · Revision of other devices if sufficient bone stock remains IN REVERSE: The Tornier HRS is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle 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 - · Massive and non-repairable rotator cuff tear - · Revision of other devices if sufficient bone stock remains The reversed tray and polyethyiene inset are in the conversion from an anatomic to reversed shoulder arthroplasty without the removal of the humeral assembly during revision surgery for patients with a functional deltoid muscle. Notes: - · All components are single use. - · The coated humeral stem is intended for cemented or cementless use. - · The all-poly glenoid components are intended for cemented use only - · The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation. - · Titanium humeral heads are intended for patients with suspected cobalt alloy material 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 a suspected material sensitivity to cobalt alloy. Tornier Perform Humeral System - Stem (Tornier PHS-Stem) In Anatomic: The humeral stem, humeral head coupler and humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid implant, as a total replacement. The PERFORM™ Humeral System – Stem is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility, and to relieve pain. The PERFORM Humeral System - Stem is indicated for use as a replacement of shoulder joints disabled by: · Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis - · Proximal humeral malunions - · Post-traumatic arthritis - · Revisions or fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains Titanium humeral heads are intents with suspected cobalt alloy material sensitivity. The wear properties of titanium and titanium alloys are inferior to that of cobalt alloy. A titanium humeral head is recommended for patients with a suspected material sensitivity to cobalt alloy. All components are single use. The humeral stems are intended for cementless use. The PERFORM Humeral System – Stem is intended to be used with cemented components, in a total shoulder arthroplasty. In Reverse: The PERFORM™ Humeral System – Stem is indicated for use as a replacement of a shoulder joint for patients with a functional deltoid muscle, grossly deficient rotator cuff, and pain disabled by one or more of the following: · Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis - · Pseudoparalysis or anterior superior escape - · Rotator cuff tear arthropathy - · Proximal humeral malunions - · Post-traumatic arthritis · Revisions or fractures of the humere adequate fixation can be achieved and adequate bone stock remains The reversed insert is indicated for use for the conversion from an anatomic to reverse shoulder prosthesis without the removal of a well fixed humeral stem for patients with a functional deltoid muscle. All components are single use. The humeral stems are intended for cementless use. The PERFORM Humeral System – Stem is intended to be used with glenoid implants that are anchored to the bone with screws for non-cemented fixation.

Tornier HRS (formerly branded Aequalis Flex Revive Shoulder System) is a fully convertible anatomic and reversed shoulder arthroplasty system that is designed to be used with existing Tornier implant systems. It is a non-constrained system intended for total or partial replacement of the glenohumeral articulation. The Tornier Humeral Reconstruction System (Tornier HRS) is a line existing Aequalis™ Flex Revive™ Shoulder System (AFR) (K191318, cleared June 14, 2019) that builds upon the AFR system with additional sized distal stems, proximal bodies, and reversed insert trays, new monoblock stems, humeral head couplers and MR Conditional labeling for Tornier HRS line extension components. The Tornier Perform Humeral System (Tornier PHS-Stem) (K2013 15) is also being expanded to include additional sized Vitamin E UHMWPE reversed inserts and a renaming of these inserts for clarity.

IN ANATOMIC: The proximal body, stem, assembly screw, locking cap, optional spacer(s), and humeral head may be used together, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The Tornier HRS Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and to relieve pain. The Tornier HRS Shoulder System is indicated for use as a replacement of shoulder joints disabled by: - Rheumatoid arthritis with pain - Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) - Correction of functional deformity - Fractures of the humeral head - Traumatic arthritis - Revision of other devices if sufficient bone stock remains IN REVERSE: The Tornier HRS Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle 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 - Massive and non-repairable rotator cuff tear - Revision of the devices if sufficient bone stock remains The reversed tray and polyethylene insert are indicated for use in the conversion from an anatomic to reversed shoulder arthroplasty without the removal of the humeral assembly during revision surgery for patients with a functional deltoid muscle. Notes: - All components are single use. - The coated humeral stem is intended for cemented or cementless use. - The all-poly glenoid components are intended for cemented use only. - The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation. - Titanium humeral heads are intended for patients with suspected cobalt alloy material 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 a suspected material sensitivity to cobalt alloy.

Tornier HRS (formerly branded Aequalis™ Flex Revive™ Shoulder System) is a fully convertible anatomic and reversed shoulder arthroplasty system that is designed to be used with existing Tornier implant system intended for total or partial replacement of the glenohumeral articulation. Tornier HRS includes a proximal body (metaphysis), a stem, assembly screw, and locking cap. The proximal body has a female taper that is compatible with Tornier Flex (formerly branded Ascend Flex) Humeral Heads and Tornier Flex (formerly branded Ascend Flex) reversed trays and poly inserts. Tornier HRS is implanted by a surgeon and is designed to select the components to size the shoulder system for the patient. It allows the shoulder to be constructed in an anatomical or reversed configuration using cleared Tornier Flex (formerly branded Ascend Flex) Humeral Heads and Tornier Flex (formerly branded Ascend Flex) reversed trays and inserts. In addition, Tornier HRS can be transformed from anatomic to reverse shoulder prosthesis without the humeral implant assembly during revision surgery. The humeral length is measured to determine the overall humeral implant construct length is assembled from 120 mm (using the short proximal body and stem) to 300 mm (using the standard proximal body, spacers, and stem) in 10 mm increments with the spacers as needed and either of the two available lengths of the proximal body for patient specificity. The proximal body, stem, and spacers are made from Ti6A4V per ASTM F-136. The proximal body and stem have a Titanium plasma spray coating. The assembly screw and locking cap are made of CoCr per ISO 5832-12. All implant parts are single use and packaged sterile, using gamma radiation at a minimum dose of 25 kGy to an SAL of 1x10-6.

The Arthrex Univers Apex OptiFit Humeral Stem is indicated in replacement when conditions include severe pain or significant disability resulting from degenerative, theumatic disease, or injury of the glenohumeral joint; nonunion humeral head fractures of long duration; irreducible 2- and 4- part proximal humeral fractures; of the humeral head; or other difficult clinical management problems where arthrodesis or re-sectional arthroplasty is not acceptable. The glenoid components are designed fixation in the joint and must only be used with an appropriate bone cement.

The proposed Univers Apex OptiFit Humeral Stem is the humeral stem component of a shoulder prosthesis system. It consists of a stem, a trunion, an inclination block, pins, and screws. All the components are comprised of titanium with a titanium plasma spray (TPS) coating.

The AltiVate® Anatomic Shoulder System is indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to: · Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis of the natural humeral head and/or glenoid, and post traumatic arthritis - · Rheumatoid and other inflammatory arthritis - · Correction of functional deformity, including fracture malunion - · Humeral head fracture - · Revision of other devices if sufficient bone stock remains The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for a total shoulder arthroplasty. Humeral components with a porous coated surface are indicated for either cemented or uncemented applications. Glenoid components are indicated for cemented use only.

This application is to include the AltiVate® Anatomic Shoulder AG e+™ with Markers (Full-Wedge), as a component of the AltiVate® Anatomic Shoulder System. The AltiVate® Anatomic Shoulder AG e+™ with Markers are manufactured from ultra-high molecular weight polyethylene with vitamin E. The articulating surface has a radius of curvature greater than the compatible humeral heads to allow translation in the superior/inferior and anterior/posterior directions. The back surface(s) of the component is spherical in geometry and has four pegs for fixation in the glenoid. The central peg has three annular barbs and the peripheral pegs have machined fixation features, referred to as Tri-lobes, to provide immediate fixation to the patient's glenoid when inserted. Radiographic markers are found in all three peripheral pegs.

In Anatomic: The stem and head may be used by themselves, as a hemiathroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The AETOS Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and to relieve pain. The AETOS Shoulder System is indicated for use as a replacement of shoulder joints disabled by: - Rheumatoid arthritis - Non-inflammatory degenerative joint disease - Correction of functional deformity - Fractures of the humeral head - Traumatic arthritis - Revision of other devices if sufficient bone stock remains The coated humeral component is intended for uncement is intended for cement is intended for cemented use only. In Reverse: The AETOS Shoulder System 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 - Correction of functional deformity - Fractures of the humeral head - Traumatic arthritis - Revision of devices if sufficient bone stock remains The humeral liner component is indicated for use in the AETOS Shoulder System as a primary reverse total shoulder replacement and for use when converting an anatomic AETOS Shoulder System into a reverse shoulder construct. This facilitates the conversion without the removal of the humeral stem during revision surgery for patients with a functional deltoid muscle. The component is permitted to be used in the conversion from anatomic to reverse if the humeral stem is well fixed, the patient has a functional deltoid muscle; the arthroplasty is associated with a massive and non-repairable rotator cuff tear. The coated humeral stem is indicated for uncemented use. The coated glenoid baseplate is intended for cementless application with the addition of screws for fixation. Note: All implant components are single use.

The AETOS Shoulder System consists of: In an anatomic configuration: A humeral stem (Titanium) with a plasma spray coating (Titanium), a compatible humeral head (CoCr) with a compatible glenoid (UHMWPE). The AETOS Shoulder System stem and head may be used by themselves for hemiarthroplasty. In a reverse configuration: A humeral stem (Titanium) with a plasma spray coating (Titanium), a compatible liner (UHMWPE), glenoid baseplate (Titanium with Titanium plasma spray), glenosphere (CoCr with Titanium retaining component), peripheral screws (Titanium), center screw (Titanium), optional humeral spacer (Titanium), and optional post extension (Titanium with Titanium plasma spray).

The AETOS Shoulder System is intended for: • Replacement of shoulder joints in primary anatomic or primary reverse arthroplasty. • Replacement of shoulder joint devices in revision cases if sufficient bone stock is present. • The AETOS Shoulder System also allows for conversions from anatomic to reverse in case of revision. Indications for Use In Anatomic: The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The AETOS Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain. The AETOS Shoulder System is indicated for use as a replacement of shoulder joints disabled by: • Rheumatoid arthritis • Non-inflammatory degenerative joint disease • Correction of functional deformity • Fractures of the humeral head • Traumatic arthritis • Revision of other devices if sufficient bone stock remains The coated humeral component is intended for uncemented use. The glenoid component is intended for cemented use only. In Reverse: The AETOS Shoulder System 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 • Correction of functional deformity • Fractures of the humeral head • Traumatic arthritis • Revision of devices if sufficient bone stock remains The humeral liner component is indicated for use in the AETOS Shoulder System as a primary reverse total shoulder replacement and for use when converting an anatomic AETOS Shoulder System into a reverse shoulder construct. This facilitates the conversion without the removal of the humeral stem during revision surgery for patients with a functional deltoid muscle. The component is permitted to be used in the conversion from anatomic to reverse if the humeral stem is well fixed, the patient has a functional deltoid muscle; the arthroplasty is associated with a massive and non-repairable rotator cuff tear. The coated humeral stem is indicated for uncemented use. The coated glenoid baseplate is intended for cementless application with the addition of screws for fixation. Note: All implant components are single use.

The AETOS Shoulder System consists of: In an anatomic configuration: A humeral stem (Titanium) with a plasma spray coating (Titanium), a compatible humeral head (CoCr) with a compatible glenoid (UHMWPE). The AETOS Shoulder System stem and head may be used by themselves for hemiarthroplasty. In a reverse configuration: A humeral stem (Titanium) with a plasma spray coating (Titanium), a compatible liner (UHMWPE), glenoid baseplate (Titanium with Titanium plasma spray), glenosphere (CoCr with Titanium retaining component), peripheral screws (Titanium), center screw (Titanium), and optional post extension (Titanium with Titanium plasma spray).

The Catalyst EA Convertible Stemmed Shoulder is intended for use as a replacement of shoulder joints in anatomic or reverse arthroplasty. Should the need arise for a conversion from an anatomic total shoulder to a reverse total shoulder, the humeral stem can remain in place, while the articulating surfaces are exchanged.

The Catalyst EA Convertible Stemmed Shoulder is an anatomic designed total shoulder prosthesis that mates with the Catalyst R1 humeral stems cleared in K202611. This submission adds conversion adapters, locking screw and humeral heads to mate with the previously cleared Catalyst R1 humeral stems. The humeral head components are compatible with previously cleared CSR 3 Peg glenoid components or for articulation with the glenoid cavity of the scapula. When the humeral stem (cleared K202611), adapter and humeral head are mated together, this creates a hemiarthroplasty (product code HSD). When the humeral stem, adapter and humeral head are used in conjunction with the CSR glenoid components (cleared K191811 and K173812), this creates a total shoulder arthroplasty (product code KWS). The adapters and locking screw are manufactured from Ti-6A1-4V ELI conforming to ASTM F136. The humeral components are manufactured from Co-Cr-Mo alloy conforming to ASTM F1537.

The AltiVate® Anatomic Shoulder System is indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to: • Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis of the natural humeral head and/or glenoid, and post traumatic arthritis · Rheumatoid and other inflammatory arthritis - · Correction of functional deformity, including fracture malunion - · Humeral head fracture - · Revision of other devices if sufficient bone stock remains The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for a total shoulder arthroplasty. Humeral components with a porous coated surface are indicated for either cemented applications. Glenoid components are indicated for cemented use only.

This application is to include the AltiVate® Anatomic Shoulder AG e+™ with Markers, as a component of the AltiVate® Anatomic Shoulder System. The AltiVate® Anatomic Shoulder AG e+™ with Markers are manufactured from ultra-high molecular weight polyethylene with vitamin E. The articulating surface has a radius of curvature greater than the compatible humeral heads to allow translation in the superior/inferior and anterior/posterior directions. The back surface(s) of the component is spherical in geometry and has four pegs for fixation in the glenoid. The central peg has three annular barbs and the peripheral pegs have machined fixation features, referred to as Tri-lobes, to provide immediate fixation to the patient's glenoid when inserted. Radiographic markers are found in all three peripheral pegs.

The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement. The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to: - non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; - inflammatory degenerative joint disease such as rheumatoid arthritis; - treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods; - revision of a failed primary implant; in case of SMR Short Stems only 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). The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The SMR TT Hybrid Glenoid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed. The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs are intended for cemented and uncemented use as specified in the following table.

The SMR Shoulder System is a shoulder system. The SMR TT Hybrid Glenoid and the SMR 3-Pegs Cemented Glenoid are glenoid components intended to be used in combination with the previously cleared components of the SMR Shoulder System (humeral stems, humeral bodies, adaptor tapers, humeral heads) to achieve an anatomic configuration. The purpose of the Special 510(k) is to add an alternative sterilization method for SMR TT Hybrid Glenoid and SMR 3-Pegs Cemented Glenoid. The SMR TT Hybrid Glenoid is composed by a poly baseplate and a peg. The poly baseplate is manufactured from conventional (non-crosslinked) UHMWPE (ISO 5834-2 ASTM F648) and Tantalum (ISO 13782 ASTM F560). The peg is manufactured from Ti6Al4V (ISO 5832-3 ASTM F1472). The SMR 3-Pegs Cemented Glenoid is manufactured from conventional (non-crosslinked) UHMWPE (ISO 5834-2 ASTM F648). The SMR TT Hybrid Glenoid and SMR 3-Pegs Cemented Glenoid can be sterilized using a minimum gamma radiation dose of 25 kGy.