Device typeTotal shoulder prosthesis: A sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes glenoid and humeral (head and stem) components typically with parts made of metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.
FDA categoryTotal shoulder arthroplasty system
Device ID00888867059955
Catalog numberAR-9301-04
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Conditional