Device Dossier
RSP Humeral Socket Insert E+ - Reverse shoulder prosthesis cup
Device Dossier for RSP Humeral Socket Insert E+ - Reverse shoulder prosthesis cup (Reverse shoulder prosthesis cup, Class III, sponsor Enovis Surgical).…
- GMDN category: Reverse shoulder prosthesis cup
Intended purpose
A component of 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.
Functional description
The RSP E+ socket insert is manufactured from Vitamin E infused UHMWPE. It is designed to be pressed into the humeral shell via a snap feature, and the humeral shell and polyethylene insert also have mating scallops to mitigate rotation. The semi constrained liner deepens the articulation with the glenosphere compared to the standard insert.