Device Dossier
METS Proximal Humeral Modular System, humeral head - Humeral head prosthesis
Device Dossier for METS Proximal Humeral Modular System, humeral head - Humeral head prosthesis (Humeral head prosthesis, Class III, sponsor Stryker).…
- GMDN category: Humeral head prosthesis
- Sponsor: Stryker
Intended purpose
The Humeral head is a component of the METS Proximal Humeral Modular System which is designed as a modular system that can be used to replace diseased or deficient bone of the proximal humerus. The METS Proximal Humeral Modular System is indicated for: - Primary bone tumour - Secondary tumour arising in bone - Non-neoplastic conditions affecting the shafts of long bones - Failed joint replacements - Failed massive replacements.
Functional description
The Humeral head is a titanium head available in Ø 43, 46, 49mm for the small humeral component and 52, 55 and 58 mm for the standard humeral component used in hemi-arthroplasty procedures. The Humeral Head is assembled together with the humeral component. A screw is inserted into the back of the humeral component so that it leads into the humeral head and tightened using a T-handled Allen/Hex key. The humeral component is then cemented securely into place ensuring correct rotational alignment.