MBF — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Class II
FDA product code MBF covers "Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented", a Class II medical device regulated under 21 CFR 888.3670. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MBF
- Device Class
- Class II
- Regulation Number
- 888.3670
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253592 | zimmer | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity H | April 13, 2026 |
| K251098 | zimmer | Identity Revision Humeral Stems | August 11, 2025 |
| K250848 | zimmer | Identity Shoulder System | July 2, 2025 |
| K240876 | zimmer | Identity Shoulder System | June 12, 2024 |
| K233712 | lima corporate | PRIMA Humeral System; PRIMA TT Glenoid | January 11, 2024 |
| K231099 | lima corporate | SMR Hybrid Glenoid System | December 21, 2023 |
| K230831 | depuy ireland uc | INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid | November 13, 2023 |
| K231516 | depuy ireland uc | INHANCE Shoulder System, Sterile Single Use Instrumentation | July 21, 2023 |
| K223876 | lima corporate | SMR Shoulder System | February 3, 2023 |
| K222427 | lima corporate | PRIMA TT Glenoid | October 6, 2022 |
| K213856 | zimmer | Identity Shoulder System | September 15, 2022 |
| K212933 | depuy ireland uc | INHANCETM Hybrid Anatomic Glenoid Implant | June 8, 2022 |
| K220792 | lima corporate | SMR Reverse Liner | May 19, 2022 |
| K202716 | ignite orthopedics | Ignite Anatomic Shoulder System | May 20, 2021 |
| K201905 | lima corporate | SMR 140° Reverse Humeral Body | December 17, 2020 |
| K193038 | biomet manufacturing | Comprehensive Shoulder System | October 28, 2020 |
| K191963 | lima corporate | SMR Finned Short Stems | October 10, 2019 |
| K183553 | biomet | Compress and Mini Compress Anti-Rotation Spindles | January 22, 2019 |
| K173824 | shoulder innovations | Humeral Short Stem System | October 23, 2018 |
| K163397 | lima corporate | SMR Hybrid Glenoid System | June 29, 2017 |