MBF

Injury

597

Total

597

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• 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
• K060692 — COMPREHENSIVE PRIMARY SHOULDER STEMS Biomet Manufacturing Corp · 2006-05-30
• K043100 — BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS Biomet, Inc. · 2005-02-17
• K032895 — BI-ANGULAR SHOULDER SYSTEM Biomet, Inc. · 2003-11-20
• K010635 — INTERLOK / HA COPELAND RESURFACING HEADS Biomet, Inc. · 2001-08-20
• K011099 — GLOBAL FX POROUS-COATED HUMERAL STEM DePuy Orthopaedics, Inc. · 2001-07-06
• K011047 — GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT DePuy Orthopaedics, Inc. · 2001-06-28
• K844415 — POROCOAT NEW JERSEY SHOULDER REPLACEMENT SYS Depuy, Inc. · 1985-01-23