FDA product code MBF: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
MBF is the FDA product code for prosthesis, shoulder, semi-constrained, metal/polymer, uncemented. It is a Class II device, regulated under 21 CFR 888.3670 and reviewed by the Orthopedic panel. FDA has cleared 37 510(k) submissions under MBF, 13 in the last five years, from 15 different applicants. The average 510(k) review took 139 days (median 100); 108 days on average over the last three years. FDA has posted 20 recalls for MBF devices, 13 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented |
| Device class | Class II |
| Regulation | 21 CFR 888.3670 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for MBF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 232 |
| 2018 | 1 | 309 |
| 2019 | 2 | 56 |
| 2020 | 2 | 262 |
| 2021 | 1 | 245 |
| 2022 | 4 | 166 |
| 2023 | 4 | 144 |
| 2024 | 2 | 64 |
| 2025 | 2 | 114 |
| 2026 | 1 | 147 |
Compare with all 510(k) review times · Search every MBF clearance
Top MBF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Lima Corporate S.P.A. | 8 | 2024-01-11 |
| Zimmer, Inc. | 5 | 2026-04-13 |
| Biomet, Inc. | 5 | 2019-01-22 |
| Biomet Manufacturing Corp | 4 | 2020-10-28 |
| Depuy Ireland UC | 3 | 2023-11-13 |
10 more applicants have MBF clearances. See the full list in Caduvo.
Most recent MBF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253592 | Zimmer, Inc. | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) | 2026-04-13 | 147 |
| K251098 | Zimmer, Inc. | Identity Revision Humeral Stems | 2025-08-11 | 123 |
| K250848 | Zimmer, Inc. | Identity Shoulder System | 2025-07-02 | 104 |
| K240876 | Zimmer, Inc. | Identity Shoulder System | 2024-06-12 | 75 |
| K233712 | Lima Corporate S.P.A. | PRIMA Humeral System; PRIMA TT Glenoid | 2024-01-11 | 52 |
Recalls for MBF devices
20 product recalls in 11 recall events; 13 initiated in the last five years and 5 still open. Most recent: 2025-03-03.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 2 |
| 2020 | 1 |
| 2022 | 8 |
| 2023 | 4 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code MBF?
MBF is the FDA product code for prosthesis, shoulder, semi-constrained, metal/polymer, uncemented. It is a Class II device, regulated under 21 CFR 888.3670 and reviewed by the Orthopedic panel.
What device class is MBF?
Class II, regulation 21 CFR 888.3670. Typical premarket route: 510(k).
How long does a 510(k) take for product code MBF?
Across 37 cleared submissions the average was 139 days from receipt to decision (median 100).
Which companies have the most MBF clearances?
Lima Corporate S.P.A. (8); Zimmer, Inc. (5); Biomet, Inc. (5); Biomet Manufacturing Corp (4); Depuy Ireland UC (3).
Have MBF devices been recalled?
Yes: 20 product recalls across 11 recall events; the most recent began 2025-03-03.
Next steps
- Run an FDA pathway report with predicate devices for product code MBF
- Run a recall and safety report across every MBF manufacturer
- Watch product code MBF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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