MBF — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Class II
FDA Device Classification
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 |
|---|
| 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 |
| K162068 | fournitures hospitalieres industrie | ARROW Anatomical Porous glenoid | April 10, 2017 |