Atlas FDA

MBF

37 FDA 510(k) clearances · Product code

100 daysmedian time to decision
266 days90th percentile
37clearances measured

FDA profile

Official device name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3670
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 36 · 2022: 114 · 2023: 143 · 2024: 164 · 2025: 256 · 2026: 168
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) (K253592)Zimmer, Inc.2026-04-13
Identity Revision Humeral Stems (K251098)Zimmer, Inc.2025-08-11
Identity Shoulder System (K250848)Zimmer, Inc.2025-07-02
Identity Shoulder System (K240876)Zimmer, Inc.2024-06-12
PRIMA Humeral System; PRIMA TT Glenoid (K233712)Lima Corporate S.P.A.2024-01-11
SMR Hybrid Glenoid System (K231099)Lima Corporate S.P.A.2023-12-21
INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid (K230831)Depuy Ireland UC2023-11-13
INHANCE™ Shoulder System, Sterile Single Use Instrumentation (K231516)Depuy Ireland UC2023-07-21
SMR Shoulder System (K223876)Lima Corporate S.P.A.2023-02-03
PRIMA TT Glenoid (K222427)Lima Corporate S.P.A.2022-10-06
Identity Shoulder System (K213856)Zimmer, Inc.2022-09-15
INHANCETM Hybrid Anatomic Glenoid Implant (K212933)Depuy Ireland UC2022-06-08
SMR Reverse Liner (K220792)Lima Corporate S.P.A.2022-05-19
Ignite Anatomic Shoulder System (K202716)Ignite Orthopedics, LLC2021-05-20
SMR 140° Reverse Humeral Body (K201905)Lima Corporate S.P.A.2020-12-17
Comprehensive Shoulder System (K193038)Biomet Manufacturing Corp2020-10-28
SMR Finned Short Stems (K191963)Lima Corporate S.P.A.2019-10-10
Compress and Mini Compress Anti-Rotation Spindles (K183553)Biomet, Inc.2019-01-22
Humeral Short Stem System (K173824)Shoulder Innovations, Inc.2018-10-23
SMR Hybrid Glenoid System (K163397)Lima Corporate S.P.A.2017-06-29
ARROW Anatomical Porous glenoid (K162068)Fournitures Hospitalieres Industrie2017-04-10
TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS (K140390)Biomet Manufacturing Corp2014-09-10
SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM (K130126)Biomet, Inc.2013-08-06
COMPRESS SEGMENTAL HUMERAL REPLACEMENT SYSTEM (K123297)Biomet Manufactuting Corp.2012-11-20
COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM (K112905)Biomet Orthopedics, LLC2012-05-24
SYNTHES EPOCA SHOULDER PROSTHESIS SYSTEM (K083439)Synthes (Usa)2009-02-05
ENCORE SHOULDER REVISION GLENOID (K081448)Encore Medical L.P.2008-09-30
COFIELD TOTAL SHOULDER SYSTEM (K070565)Smith & Nephew, Inc.2007-05-18
GLOBAL AP POROUS COATED HUMERAL STEM (K063652)DePuy Orthopaedics, Inc.2007-02-01
VERSA-DIAL HUMERAL HEAD PROSTHESIS (K060716)Biomet Manufacturing Corp2006-06-12
COMPREHENSIVE PRIMARY SHOULDER STEMS (K060692)Biomet Manufacturing Corp2006-05-30
BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS (K043100)Biomet, Inc.2005-02-17
BI-ANGULAR SHOULDER SYSTEM (K032895)Biomet, Inc.2003-11-20
INTERLOK / HA COPELAND RESURFACING HEADS (K010635)Biomet, Inc.2001-08-20
GLOBAL FX POROUS-COATED HUMERAL STEM (K011099)DePuy Orthopaedics, Inc.2001-07-06
GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT (K011047)DePuy Orthopaedics, Inc.2001-06-28
POROCOAT NEW JERSEY SHOULDER REPLACEMENT SYS (K844415)Depuy, Inc.1985-01-23

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Every clearance here is in the API, with alerts when new ones post.