MBF
- Product code
- MBF
- Device name
- Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3670
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 37
510(k) clearances, last 3 years (7)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253592 | 2026-04-13 | Zimmer, Inc. | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance | |
| K251098 | 2025-08-11 | Zimmer, Inc. | Identity Revision Humeral Stems | |
| K250848 | 2025-07-02 | Zimmer, Inc. | Identity Shoulder System | |
| K240876 | 2024-06-12 | Zimmer, Inc. | Identity Shoulder System | FDA |
| K233712 | 2024-01-11 | Lima Corporate S.P.A. | PRIMA Humeral System; PRIMA TT Glenoid | |
| K231099 | 2023-12-21 | Lima Corporate S.P.A. | SMR Hybrid Glenoid System | |
| K230831 | 2023-11-13 | Depuy Ireland UC | INHANCE Shoulder System Convertible Glenoid Inserts, |
Official FDA classification page: MBF
Classification and pathway per current FDA publications. Data from openFDA (CC0).