Encore Medical L.P. · Class II · Cleared Jan 15, 2026
| K-number | K252567 |
| Device name | AltiVate Reverse® ADLC Glenosphere |
| Applicant | Encore Medical L.P. |
| Product code | PHX |
| Device class | Class II |
| Decision date | Jan 15, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3660 |
The AltiVate Reverse® ADLC Glenosphere is a reverse shoulder prosthesis glenoid component (ball socket) intended for patients with a functional deltoid muscle and severely deficient rotator cuff. It is used to treat shoulder pain and dysfunction caused by severe arthropathy, failed prior replacements, fractures, arthritis, or bone defects in the shoulder joint.
The subject device consists of glenospheres manufactured from titanium alloy (Ti-6Al-4V) with an amorphous diamond-like carbon (ADLC) coating on the articulating surface. The predicate device glenospheres are manufactured from cobalt-chrome alloy without ADLC coating. Both are designed for cementless application with screw fixation.
Not stated in this summary.
The AltiVate Reverse® ADLC Glenosphere is substantially equivalent to the predicate Reverse Shoulder Prosthesis® (RSP) Glenosphere in indications for use, function, and overall design. Testing including wear, disassembly, fretting corrosion, range of motion, glenoid stability, coating characterization, and MRI compatibility demonstrates equivalent performance, supporting substantial equivalence despite the material and coating differences.
View the full FDA submission: accessdata.fda.gov