MBFClass II
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
21 CFR 888.3670 / Orthopedic
MBF is the FDA product code for Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented, a class II device type, regulated under 21 CFR 888.3670. As of , FDA records hold 37 510(k) clearances under this code, the most recent dated , and 20 recalls.
Classification record
- Product code
- MBF
- Device name
- Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
- Regulation
- 21 CFR 888.3670
- Device class
- Class II
- Review panel
- Orthopedic
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 37
- Ingested recalls
- 20
Clearances, product code MBF
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1985 | 1 |
| 2001 | 3 |
| 2003 | 1 |
| 2005 | 1 |
| 2006 | 2 |
| 2007 | 2 |
| 2008 | 1 |
| 2009 | 1 |
| 2012 | 2 |
| 2013 | 1 |
| 2014 | 1 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 2 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 4 |
| 2023 | 4 |
| 2024 | 2 |
| 2025 | 2 |
| 2026 | 1 |
Applicants with the most clearances
Product code MBF| Applicant | Clearances |
|---|---|
| Zimmer GmbH | 10 |
| Lima Corporate S.p.A. | 8 |
| Biomet Manufacturing Corp | 4 |
| Depuy Orthopaedics Inc. | 3 |
| Depuy Ireland UC | 3 |
| Biomet Manufactuting Corp. | 1 |
| Biomet Orthopedics, Inc. | 1 |
| Depuy, Inc. | 1 |
| Encore Medical, LP | 1 |
| Fournitures Hospitalieres Industrie | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.