Device Dossier

RSP Monoblock Hemi Adapter - Reverse shoulder prosthesis

Device Dossier for RSP Monoblock Hemi Adapter - Reverse shoulder prosthesis (Reverse shoulder prosthesis, Class III, sponsor Enovis Surgical). ARTG…

Intended purpose

During primary surgery, after the humerus is prepared for the RSP humeral stem (modular and monoblock), if purchase to the glenoid bone is insufficient to bear the load of the glenoid baseplate and alternative glenoid bone reconstruction and/or repair is inadequate, the corresponding RSP humeral stem adapter can be used to convert the RSP humeral stem to hemiarthroplasty prosthesis as a salvage procedure. During revision surgery of an RSP (modular or monoblock), if the glenoid bone stock appears to be insufficient to bear the load of the glenoid baseplate and alternative glenoid bone reconstruction and/or repair is inadequate, the corresponding RSP humeral stem adapter can be used to convert the RSP device to hemiarthroplasty prosthesis as a salvage procedure. For modular RSP stems, the Foundation Shoulder humeral head should be used. For the monoblock stem, the Turon humeral head should be used. This stem/adapter construct is not approved for use as a surrogate for traditional hemiarthroplasty or anatomic replacement indications.

Functional description

The RSP® Monoblock Stem Hemi Adapter utilizes Ti-6Al-4V screw to retain the CoCr adapter to the Ti-6Al-4V stem socket. The hemi adapter, manufactured from CoCr, inserts into the socket of the monoblock humeral stem. It has tabs that interlock with the two opposed notches in the socket to prevent rotation. The adapter is then secured to the stem with a Ti6Al4V retaining screw that passes through the neck of the adapter and threads into the hole at the base of the stem socket.

TGA Public Summary