AltiVate Reverse® Glenoid

The AltiVate Reverse® Glenoid is a reverse shoulder prosthesis glenoid baseplate intended for cementless application with screw fixation. It is indicated for reverse shoulder replacement in patients with a functional deltoid muscle and grossly deficient rotator cuff suffering from conditions including severe arthropathy, failed joint replacements, fractures, osteoarthritis, rheumatoid arthritis, and avascular necrosis.

This submission does not introduce any new implants, instruments, or changes to device design, materials, function, or intended use. The only change is an updated surgical technique in labeling that adds an alternative reaming method to prepare the glenoid surface, supplementing rather than replacing the original technique.

Not stated in this summary.

Substantial equivalence is established because there are no differences in intended use, design, material, manufacturing process, sterilization, packaging, or principle of operation between the subject and predicate devices. The alternative surgical technique is purely instructional and does not modify the physical device or its fundamental function, and design control and verification/validation activities demonstrated no new safety or effectiveness concerns.