Product code MBF
- Device name
- Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3670
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253592 | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) | Zimmer, Inc. | 2026-04-13 |
| K251098 | Identity Revision Humeral Stems | Zimmer, Inc. | 2025-08-11 |
| K250848 | Identity Shoulder System | Zimmer, Inc. | 2025-07-02 |
| K240876 | Identity Shoulder System | Zimmer, Inc. | 2024-06-12 |
| K233712 | PRIMA Humeral System; PRIMA TT Glenoid | Lima Corporate S.P.A. | 2024-01-11 |
| K231099 | SMR Hybrid Glenoid System | Lima Corporate S.P.A. | 2023-12-21 |
| K230831 | INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid | Depuy Ireland UC | 2023-11-13 |
| K231516 | INHANCE™ Shoulder System, Sterile Single Use Instrumentation | Depuy Ireland UC | 2023-07-21 |
| K223876 | SMR Shoulder System | Lima Corporate S.P.A. | 2023-02-03 |
| K222427 | PRIMA TT Glenoid | Lima Corporate S.P.A. | 2022-10-06 |
| K213856 | Identity Shoulder System | Zimmer, Inc. | 2022-09-15 |
| K212933 | INHANCETM Hybrid Anatomic Glenoid Implant | Depuy Ireland UC | 2022-06-08 |
| K220792 | SMR Reverse Liner | Lima Corporate S.P.A. | 2022-05-19 |
| K202716 | Ignite Anatomic Shoulder System | Ignite Orthopedics, LLC | 2021-05-20 |
| K201905 | SMR 140° Reverse Humeral Body | Lima Corporate S.P.A. | 2020-12-17 |
| K193038 | Comprehensive Shoulder System | Biomet Manufacturing Corp | 2020-10-28 |
| K191963 | SMR Finned Short Stems | Lima Corporate S.P.A. | 2019-10-10 |
| K183553 | Compress and Mini Compress Anti-Rotation Spindles | Biomet, Inc. | 2019-01-22 |
| K173824 | Humeral Short Stem System | Shoulder Innovations, Inc. | 2018-10-23 |
| K163397 | SMR Hybrid Glenoid System | Lima Corporate S.P.A. | 2017-06-29 |
| K162068 | ARROW Anatomical Porous glenoid | Fournitures Hospitalieres Industrie | 2017-04-10 |
| K140390 | TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS | Biomet Manufacturing Corp | 2014-09-10 |
| K130126 | SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM | Biomet, Inc. | 2013-08-06 |
| K123297 | COMPRESS SEGMENTAL HUMERAL REPLACEMENT SYSTEM | Biomet Manufactuting Corp. | 2012-11-20 |
| K112905 | COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM | Biomet Orthopedics, LLC | 2012-05-24 |
| K083439 | SYNTHES EPOCA SHOULDER PROSTHESIS SYSTEM | Synthes (Usa) | 2009-02-05 |
| K081448 | ENCORE SHOULDER REVISION GLENOID | Encore Medical L.P. | 2008-09-30 |
| K070565 | COFIELD TOTAL SHOULDER SYSTEM | Smith & Nephew, Inc. | 2007-05-18 |
| K063652 | GLOBAL AP POROUS COATED HUMERAL STEM | DePuy Orthopaedics, Inc. | 2007-02-01 |
| K060716 | VERSA-DIAL HUMERAL HEAD PROSTHESIS | Biomet Manufacturing Corp | 2006-06-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B1132A2HI000100 | Shoulder Innovations InSet 95 Humeral Stem | Shoulder Innovations, Inc. | 2026-05-28 |
| 08033390002233 | SMR System | LIMACORPORATE SPA | 2026-02-19 |
| 08033390002240 | SMR System | LIMACORPORATE SPA | 2026-02-19 |
| 08033390002257 | SMR System | LIMACORPORATE SPA | 2026-02-19 |
| 08033390050036 | SMR System | LIMACORPORATE SPA | 2026-02-19 |
| 08033390050029 | SMR System | LIMACORPORATE SPA | 2026-02-19 |
| 08033390115667 | SMR TT Hybrid Glenoid | LIMACORPORATE SPA | 2024-07-27 |
| 08033390106788 | BONE SCREWS | LIMACORPORATE SPA | 2020-11-27 |
| 08033390106771 | BONE SCREWS | LIMACORPORATE SPA | 2020-11-27 |
| 08033390106764 | BONE SCREWS | LIMACORPORATE SPA | 2020-11-27 |
| 08033390106757 | BONE SCREWS | LIMACORPORATE SPA | 2020-11-27 |
| 08033390106856 | BONE SCREWS | LIMACORPORATE SPA | 2019-11-28 |
| 08033390106870 | BONE SCREWS | LIMACORPORATE SPA | 2019-11-28 |
| 08033390106894 | BONE SCREWS | LIMACORPORATE SPA | 2019-11-28 |
| 08033390106825 | BONE SCREWS | LIMACORPORATE SPA | 2019-11-28 |
| 08033390106801 | BONE SCREWS | LIMACORPORATE SPA | 2019-11-28 |
| 08033390106917 | BONE SCREWS | LIMACORPORATE SPA | 2019-11-28 |
| 08033390106931 | BONE SCREWS | LIMACORPORATE SPA | 2019-11-28 |
| 08033390115674 | SMR TT Hybrid Glenoid | LIMACORPORATE SPA | 2017-07-05 |
| 08033390115681 | SMR TT Hybrid Glenoid | LIMACORPORATE SPA | 2017-07-05 |
| 08033390087834 | SMR Shoulder | LIMACORPORATE SPA | 2017-07-05 |
| 08033390085984 | SMR Shoulder | LIMACORPORATE SPA | 2017-07-05 |
| 08033390018913 | BONE SCREWS | LIMACORPORATE SPA | 2015-07-31 |
| 08033390018906 | BONE SCREWS | LIMACORPORATE SPA | 2015-07-31 |
| 08033390018890 | BONE SCREWS | LIMACORPORATE SPA | 2015-07-31 |
| 08033390018883 | BONE SCREWS | LIMACORPORATE SPA | 2015-07-31 |
| 08033390018876 | BONE SCREWS | LIMACORPORATE SPA | 2015-07-31 |
| 08033390018869 | BONE SCREWS | LIMACORPORATE SPA | 2015-07-31 |
| 08033390018852 | BONE SCREWS | LIMACORPORATE SPA | 2015-07-31 |
| 08033390018845 | BONE SCREWS | LIMACORPORATE SPA | 2015-07-31 |