Device Dossier
Aequalis Reversed Fracture Hemi Prosthesis Adaptor - Reverse shoulder prosthesis
Device Dossier for Aequalis Reversed Fracture Hemi Prosthesis Adaptor - Reverse shoulder prosthesis (Reverse shoulder prosthesis, Class III, sponsor…
- GMDN category: Reverse shoulder prosthesis
- Sponsor: Stryker
Intended purpose
A component of the Aequalis Reversed Fracture Shoulder Prosthesis indicated for patients with functional deltoid muscle as a total shoulder replacement for the relief of pain/significant disability following arthropathy associated to a grossly deficient rotator cuff joint: in case of traumatic/pathologic conditions of shoulder resulting in fracture of the glenohumeral joint, including head fracture and displaced 3 or 4 part proximal fractures; or in case of bone defect in the proximal humerus.
Functional description
Allows the transformation of an implanted Aequalis Reversed Fracture prosthesis into a non-reversed hemi-prosthesis in order to avoid the revision of the humeral components. It is intended for use when the glenoid bone stock appears to be insufficient for the proper fixation of the glenoid base plate during a primary surgery or a revision.