| K-number | K251098 |
| Device name | Identity Revision Humeral Stems |
| Applicant | Zimmer, Inc. |
| Product code | MBF |
| Device class | Class II |
| Decision date | Aug 11, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3670 |
The Identity Revision Humeral Stems are titanium alloy components used in shoulder joint replacement surgery. They are indicated for hemiarthroplasty or total shoulder arthroplasty in patients with degenerative joint disease, rheumatoid arthritis, proximal humerus fractures, rotator cuff deficiency, or revision surgery. The stems can be used with or without cement and may be combined with glenoid or reverse components.
The devices are titanium alloy stems with diameters from 4mm to 18mm in 1mm increments and lengths of 133-134mm. They feature a distal cylindrical portion, proximal rounded shape, machine finish with plasma-spray titanium porous coating, and proximal suture holes. The subject device has an extended porous region compared to the primary predicate but remains within the range of the reference predicate. Packaging and sterilization are identical to predicate devices.
Not stated in this summary.
Substantial equivalence is established through identical intended use, materials matching predicate and reference devices, and similar stem diameter, length, and suture hole features within predicate ranges. Although the subject device has an extended porous region versus the primary predicate, fatigue testing demonstrated that performance is not affected by this difference. The packaging design and sterilization methods are identical to predicate devices, and no new safety or effectiveness questions are raised by the differences identified.
View the full FDA submission: accessdata.fda.gov