FDA Product Code
FDA Product Code MBF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3670
510(k) Clearances — 37 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| 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 | Traditional | PDF ↗ |
| K251098 | Identity Revision Humeral Stems | Zimmer, Inc. | 2025-08-11 | Traditional | PDF ↗ |
| K250848 | Identity Shoulder System | Zimmer, Inc. | 2025-07-02 | Traditional | PDF ↗ |
| K240876 | Identity Shoulder System | Zimmer, Inc. | 2024-06-12 | Traditional | PDF ↗ |
| K233712 | PRIMA Humeral System; PRIMA TT Glenoid | Lima Corporate S.P.A. | 2024-01-11 | Traditional | PDF ↗ |
| K231099 | SMR Hybrid Glenoid System | Lima Corporate S.P.A. | 2023-12-21 | Traditional | PDF ↗ |
| K230831 | INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid | Depuy Ireland UC | 2023-11-13 | Traditional | PDF ↗ |
| K231516 | INHANCE Shoulder System, Sterile Single Use Instrumentation | Depuy Ireland UC | 2023-07-21 | Traditional | PDF ↗ |
| K223876 | SMR Shoulder System | Lima Corporate S.P.A. | 2023-02-03 | Traditional | PDF ↗ |
| K222427 | PRIMA TT Glenoid | Lima Corporate S.P.A. | 2022-10-06 | Traditional | PDF ↗ |
| K213856 | Identity Shoulder System | Zimmer, Inc. | 2022-09-15 | Traditional | PDF ↗ |
| K212933 | INHANCETM Hybrid Anatomic Glenoid Implant | Depuy Ireland UC | 2022-06-08 | Traditional | PDF ↗ |
| K220792 | SMR Reverse Liner | Lima Corporate S.P.A. | 2022-05-19 | Traditional | PDF ↗ |
| K202716 | Ignite Anatomic Shoulder System | Ignite Orthopedics, LLC | 2021-05-20 | Traditional | PDF ↗ |
| K201905 | SMR 140° Reverse Humeral Body | Lima Corporate S.P.A. | 2020-12-17 | Traditional | PDF ↗ |
| K193038 | Comprehensive Shoulder System | Biomet Manufacturing Corp | 2020-10-28 | Traditional | PDF ↗ |
| K191963 | SMR Finned Short Stems | Lima Corporate S.P.A. | 2019-10-10 | Traditional | PDF ↗ |
| K183553 | Compress and Mini Compress Anti-Rotation Spindles | Biomet, Inc. | 2019-01-22 | Traditional | PDF ↗ |
| K173824 | Humeral Short Stem System | Shoulder Innovations, Inc. | 2018-10-23 | Traditional | PDF ↗ |
| K163397 | SMR Hybrid Glenoid System | Lima Corporate S.P.A. | 2017-06-29 | Traditional | PDF ↗ |
| K162068 | ARROW Anatomical Porous glenoid | Fournitures Hospitalieres Industrie | 2017-04-10 | Traditional | PDF ↗ |
| K140390 | TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS | Biomet Manufacturing Corp | 2014-09-10 | Traditional | PDF ↗ |
| K130126 | SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM | Biomet, Inc. | 2013-08-06 | Traditional | PDF ↗ |
| K123297 | COMPRESS SEGMENTAL HUMERAL REPLACEMENT SYSTEM | Biomet Manufactuting Corp. | 2012-11-20 | Special | PDF ↗ |
| K112905 | COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM | Biomet Orthopedics, LLC | 2012-05-24 | Traditional | PDF ↗ |
| K083439 | SYNTHES EPOCA SHOULDER PROSTHESIS SYSTEM | Synthes (Usa) | 2009-02-05 | Traditional | PDF ↗ |
| K081448 | ENCORE SHOULDER REVISION GLENOID | Encore Medical L.P. | 2008-09-30 | Traditional | PDF ↗ |
| K070565 | COFIELD TOTAL SHOULDER SYSTEM | Smith & Nephew, Inc. | 2007-05-18 | Abbreviated | PDF ↗ |
| K063652 | GLOBAL AP POROUS COATED HUMERAL STEM | DePuy Orthopaedics, Inc. | 2007-02-01 | Traditional | PDF ↗ |
| K060716 | VERSA-DIAL HUMERAL HEAD PROSTHESIS | Biomet Manufacturing Corp | 2006-06-12 | Traditional | PDF ↗ |
| K060692 | COMPREHENSIVE PRIMARY SHOULDER STEMS | Biomet Manufacturing Corp | 2006-05-30 | Traditional | PDF ↗ |
| K043100 | BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS | Biomet, Inc. | 2005-02-17 | Special | PDF ↗ |
| K032895 | BI-ANGULAR SHOULDER SYSTEM | Biomet, Inc. | 2003-11-20 | Traditional | PDF ↗ |
| K010635 | INTERLOK / HA COPELAND RESURFACING HEADS | Biomet, Inc. | 2001-08-20 | Traditional | PDF ↗ |
| K011099 | GLOBAL FX POROUS-COATED HUMERAL STEM | DePuy Orthopaedics, Inc. | 2001-07-06 | Traditional | PDF ↗ |
| K011047 | GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT | DePuy Orthopaedics, Inc. | 2001-06-28 | Traditional | PDF ↗ |
| K844415 | POROCOAT NEW JERSEY SHOULDER REPLACEMENT SYS | Depuy, Inc. | 1985-01-23 | Traditional | PDF ↗ |
Product code MBF · Class II · Orthopedic. Data: openFDA.