FDA 510(k) Applications for Medical Device Product Code "MBF"
(Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K060692 | BIOMET MANUFACTURING CORP. | COMPREHENSIVE PRIMARY SHOULDER STEMS | 05/30/2006 |
| K193038 | Biomet Manufacturing Corp. | Comprehensive Shoulder System | 10/28/2020 |
| K140390 | BIOMET MANUFACTURING CORP. | TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS | 09/10/2014 |
| K060716 | BIOMET MANUFACTURING CORP. | VERSA-DIAL HUMERAL HEAD PROSTHESIS | 06/12/2006 |
| K123297 | BIOMET MANUFACTUTING CORP. | COMPRESS SEGMENTAL HUMERAL REPLACEMENT SYSTEM | 11/20/2012 |
| K112905 | BIOMET ORTHOPEDICS LLC. | COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM | 05/24/2012 |
| K183553 | Biomet, Inc | Compress and Mini Compress Anti-Rotation Spindles | 01/22/2019 |
| K032895 | BIOMET, INC. | BI-ANGULAR SHOULDER SYSTEM | 11/20/2003 |
| K043100 | BIOMET, INC. | BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS | 02/17/2005 |
| K010635 | BIOMET, INC. | INTERLOK / HA COPELAND RESURFACING HEADS | 08/20/2001 |
| K130126 | BIOMET, INC. | SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM | 08/06/2013 |
| K230831 | Depuy Ireland UC | INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid | 11/13/2023 |
| K231516 | Depuy Ireland UC | INHANCEÖ Shoulder System, Sterile Single Use Instrumentation | 07/21/2023 |
| K212933 | Depuy Ireland UC | INHANCETM Hybrid Anatomic Glenoid Implant | 06/08/2022 |
| K011047 | DEPUY ORTHOPAEDICS, INC. | GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT | 06/28/2001 |
| K063652 | DEPUY ORTHOPAEDICS, INC. | GLOBAL AP POROUS COATED HUMERAL STEM | 02/01/2007 |
| K011099 | DEPUY ORTHOPAEDICS, INC. | GLOBAL FX POROUS-COATED HUMERAL STEM | 07/06/2001 |
| K081448 | ENCORE MEDICAL, L.P. | ENCORE SHOULDER REVISION GLENOID | 09/30/2008 |
| K162068 | Fournitures Hospitalieres Industrie | ARROW Anatomical Porous glenoid | 04/10/2017 |
| K202716 | Ignite Orthopedics LLC | Ignite Anatomic Shoulder System | 05/20/2021 |
| K233712 | LimaCorporate S.p.A | PRIMA Humeral System; PRIMA TT Glenoid | 01/11/2024 |
| K191963 | LimaCorporate S.p.A | SMR Finned Short Stems | 10/10/2019 |
| K222427 | LimaCorporate S.p.A. | PRIMA TT Glenoid | 10/06/2022 |
| K201905 | LimaCorporate S.p.A. | SMR 140░ Reverse Humeral Body | 12/17/2020 |
| K163397 | Limacorporate S.p.A. | SMR Hybrid Glenoid System | 06/29/2017 |
| K231099 | LimaCorporate S.p.A. | SMR Hybrid Glenoid System | 12/21/2023 |
| K220792 | LimaCorporate S.p.A. | SMR Reverse Liner | 05/19/2022 |
| K223876 | LimaCorporate S.p.A. | SMR Shoulder System | 02/03/2023 |
| K173824 | Shoulder Innovations Inc | Humeral Short Stem System | 10/23/2018 |
| K070565 | SMITH & NEPHEW, INC. | COFIELD TOTAL SHOULDER SYSTEM | 05/18/2007 |
| K083439 | SYNTHES (USA) | SYNTHES EPOCA SHOULDER PROSTHESIS SYSTEM | 02/05/2009 |
| K250848 | Zimmer Inc. | Identity Shoulder System | 07/02/2025 |
| K240876 | Zimmer Inc. | Identity Shoulder System | 06/12/2024 |
| K213856 | Zimmer Inc. | Identity Shoulder System | 09/15/2022 |
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