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The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy failed joint replacement and a grossly deficient rotator cuff shoulder joint.

The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.

The glenoid baseplate is intended for cementless application of screws for primary stability.

The Medacta Shoulder System is a modular system intended to be used for Reverse Shoulder Arthroplastises (RSA). The Medacta Shoulder System is composed of the following components:

• Humeral Diaphysis Cemented
• Humeral Diaphysis - Cementless
• Humeral Reverse Metaphysis
• Humeral Reverse HC Liner (also referred to as PE Liner)
• Glenoid Baseplate
• Glenoidsphere
• Glenoid Polyaxial Locking Screws
• Reverse Metaphysis Screw
• Glenoidsphere Screw

The Humeral Diaphysis and Humeral Reverse Metaphysis are intended to be assembled together by means of a cylindrical driven-fit coupling and tightened by the Reverse Metaphysis Screw. The Humeral Reverse HC Liner is intended to be coupled by means of an embedded clipping mechanism with the Humeral Reverse Metaphysis.

The Glenoid Baseplate is intended to be fixed on the glenoid bone by means of a central press-fit and with the help of Glenoid Polyaxial Locking Screws. The Glenoidsphere is intended to be assembled with the Glenoid Baseplate by means of a taper Morse connection and secured by the Glenoidsphere Screw.

The Glenoidsphere Screw, Reverse Metaphysis Screw, and Glenoid Polyaxial Locking Screws are made of Ti alloy enhanced with Type-II anodization.

This document is a 510(k) summary for the Medacta Shoulder System, a medical device. It does not describe an AI/ML device, nor does it present acceptance criteria or a study proving that an AI/ML device meets those criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, ground truth, or MRMC studies for an AI/ML device from this document.

The document discusses the substantial equivalence of the Medacta Shoulder System to predicate devices based on:

1. Indications for Use: The Medacta Shoulder System is indicated for treatment of humeral fractures and primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement and a grossly deficient rotator cuff shoulder joint.
2. Technological Characteristics: Similarities in materials (Titanium Alloy, Cobalt Chromium, UHMWPE), design, coating, thread design, device usage, and sterility to predicate devices.
3. Non-Clinical Studies: Mechanical tests (Wear, Fatigue, Static Fatigue, Micromotions Assessment), and Coating Tests following ASTM standards.
4. Biocompatibility: Demonstrated through similarities in materials to predicate devices and adherence to manufacturing standards.
5. Pyrogenicity: Assessed using Bacterial Endotoxin Test (LAL test) and Pyrogen Test according to European Pharmacopoeia and USP chapters.

No clinical studies were conducted for the Medacta Shoulder System to support the 510(k) submission.

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