Device typeUncoated shoulder humeral stem prosthesis: A sterile implantable device designed to provide fixation within the proximal humerus and a site of attachment for a humeral head or humeral body prosthesis as part of a shoulder joint replacement. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation is intended to be performed with bone cement.
FDA categoryTotal shoulder arthroplasty system
Device ID00888867139541
Catalog numberAR-9355-23
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Conditional