ClearanceBrief
Panels › Orthopedic › Product code MBF · Class 2

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

Regulation 888.3670

1510(k)s in 12 months (37 all time)
0recalls in 12 months (20 all time)
12recalls that name a 510(k)
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Top companies in MBF

Company510(k)sRecalls
Biomet, Inc.510
Lima Corporate S.P.A.80
Zimmer, Inc.50
Biomet Manufacturing Corp40
Limacorporate S.p.A04
Zimmer Biomet, Inc.04
Depuy Ireland UC30
DePuy Orthopaedics, Inc.30
Encore Medical L.P.11
Biomet Manufactuting Corp.10
Decided510(k)Device and applicantCode
Apr 13, 2026K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Hume
Zimmer, Inc.
MBF
Aug 11, 2025K251098Identity Revision Humeral Stems
Zimmer, Inc.
MBF
Jul 2, 2025K250848Identity Shoulder System
Zimmer, Inc.
MBF
Jun 12, 2024K240876Identity Shoulder System
Zimmer, Inc.
MBF
Jan 11, 2024K233712PRIMA Humeral System; PRIMA TT Glenoid
Lima Corporate S.P.A., IT
MBF
Dec 21, 2023K231099SMR Hybrid Glenoid System
Lima Corporate S.P.A., IT
MBF
Nov 13, 2023K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid
Depuy Ireland UC, IE
MBF
Jul 21, 2023K231516INHANCE™ Shoulder System, Sterile Single Use Instrumentation
Depuy Ireland UC, IE
MBF
Feb 3, 2023K223876SMR Shoulder System
Lima Corporate S.P.A., IT
MBF
Oct 6, 2022K222427PRIMA TT Glenoid
Lima Corporate S.P.A., IT
MBF
Sep 15, 2022K213856Identity Shoulder System
Zimmer, Inc.
MBF
Jun 8, 2022K212933INHANCETM Hybrid Anatomic Glenoid Implant
Depuy Ireland UC, IE
MBF
May 19, 2022K220792SMR Reverse Liner
Lima Corporate S.P.A., IT
MBF
May 20, 2021K202716Ignite Anatomic Shoulder System
Ignite Orthopedics, LLC
MBF
Dec 17, 2020K201905SMR 140° Reverse Humeral Body
Lima Corporate S.P.A., IT
MBF
Oct 28, 2020K193038Comprehensive Shoulder System
Biomet Manufacturing Corp
MBF
Oct 10, 2019K191963SMR Finned Short Stems
Lima Corporate S.P.A., IT
MBF
Jan 22, 2019K183553Compress and Mini Compress Anti-Rotation Spindles
Biomet, Inc.
MBF
Oct 23, 2018K173824Humeral Short Stem System
Shoulder Innovations, Inc.
MBF
Jun 29, 2017K163397SMR Hybrid Glenoid System
Lima Corporate S.P.A., IT
MBF
Apr 10, 2017K162068ARROW Anatomical Porous glenoid
Fournitures Hospitalieres Industrie, FR
MBF
Sep 10, 2014K140390TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS
Biomet Manufacturing Corp
MBF
Aug 6, 2013K130126SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM
Biomet, Inc.
MBF
Nov 20, 2012K123297COMPRESS SEGMENTAL HUMERAL REPLACEMENT SYSTEM
Biomet Manufactuting Corp.
MBF
May 24, 2012K112905COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM
Biomet Orthopedics, LLC
MBF
Feb 5, 2009K083439SYNTHES EPOCA SHOULDER PROSTHESIS SYSTEM
Synthes (Usa)
MBF
Sep 30, 2008K081448ENCORE SHOULDER REVISION GLENOID
Encore Medical L.P.
MBF
May 18, 2007K070565COFIELD TOTAL SHOULDER SYSTEM
Smith & Nephew, Inc.
MBF
Feb 1, 2007K063652GLOBAL AP POROUS COATED HUMERAL STEM
DePuy Orthopaedics, Inc.
MBF
Jun 12, 2006K060716VERSA-DIAL HUMERAL HEAD PROSTHESIS
Biomet Manufacturing Corp
MBF
May 30, 2006K060692COMPREHENSIVE PRIMARY SHOULDER STEMS
Biomet Manufacturing Corp
MBF
Feb 17, 2005K043100BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS
Biomet, Inc.
MBF
Nov 20, 2003K032895BI-ANGULAR SHOULDER SYSTEM
Biomet, Inc.
MBF
Aug 20, 2001K010635INTERLOK / HA COPELAND RESURFACING HEADS
Biomet, Inc.
MBF
Jul 6, 2001K011099GLOBAL FX POROUS-COATED HUMERAL STEM
DePuy Orthopaedics, Inc.
MBF
Jun 28, 2001K011047GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT
DePuy Orthopaedics, Inc.
MBF
Jan 23, 1985K844415POROCOAT NEW JERSEY SHOULDER REPLACEMENT SYS
Depuy, Inc.
MBF

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