Search Results

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 coff deficient joint with severe arthropathy (disabled shoulder). The patients 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.

In the Anatomic shoulder the humeral consists of the humeral stem, the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.

The Anatomic glenoid construct consists of an all polyethylene glenoid with metal peg or a metal back assembled with a liner; the Reverse glenoid consists of a metal back/connector/glenosphere construct or of a peg/baseplate/glenosphere construct. On the glenoid side, the fixation of the all polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented.

The SMR 140° Reverse Humeral Bodies (SMR 140° Reverse Humeral Body, SMR 140° Short Reverse Humeral Body, SMR 140° Finned Reverse Humeral Body) are manufactured from Ti6Al4V alloy (ASTM F1472 - ISO 5832-3); they are for tapercoupling with previously cleared Humeral extension (K113523), SMR CTA Head Adaptor for Reverse Humeral Body (K131112), Reverse Liners (K110598, K142139) and Humeral stems (K100858, K101263, K111212, K191963).

This document is a 510(k) premarket notification for the SMR 140° Reverse Humeral Body, a component of a shoulder replacement system. As such, it does not contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria.

The document describes a medical device (SMR 140° Reverse Humeral Body for shoulder replacement) and its substantial equivalence to predicate devices, supported by non-clinical mechanical testing. It explicitly states that clinical testing was not necessary to demonstrate substantial equivalence.

Therefore, the requested information points regarding AI acceptance criteria and studies (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, ground truth type for training/test sets, and training sample size) are not applicable to this document.

Ask a specific question about this device