Atlas FDA

HSD

71 FDA 510(k) clearances · Product code

88 daysmedian time to decision
242 days90th percentile
71clearances measured

FDA profile

Official device name
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3690
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 573 · 2022: 508 · 2023: 586 · 2024: 693 · 2025: 768 · 2026: 437
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
Univers Revers CA Head and Adapter (K233260)Arthrex, Inc.2024-02-12
Univers Revers Humeral Cup Implant (K221232)Arthrex, Inc.2022-05-19
AGILON® XO Shoulder Replacement System (K191433)Implantcast GmbH2020-11-12
Biocore9 Humeral Resurfacing System (K193122)Biocore9, LLC2020-05-15
OVOMotion Shoulder Arthroplasty System (K173964)Arthrosurface, Inc.2018-04-18
Arthrex Univers Revers Shoulder Prosthesis System (K161782)Arthrex, Inc.2016-11-21
Anatomical Shoulder Domelock Dome centric (K161620)Zimmer GmbH2016-11-01
Arthrex Univers Revers CA Heads and Adapters (K151527)Arthrex, Inc.2016-04-19
HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System (K142942)Arthrosurface, Inc.2014-12-19
EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM (K131298)Exactech, Inc.2013-11-26
HUMELOCK II CEMENTLESS SHOULDER SYSTEM (K130759)Fx Solutions2013-11-09
ARTHREX UNIVERS II CA HEADS (K130675)Arthrex, Inc.2013-10-30
SEVIIN SURFACE REPLACEMENT SHOULDER (K130635)Ingen Orthopedics, LLC2013-08-26
SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS (K121714)Smith & Nephew, Inc.2012-09-07
SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS (K112900)Lima Corporate S.P.A.2012-06-01
SPACER-S (K112983)Tecres S.P.A.2011-12-12
HUMELOCK CEMENTED SHOULDER PROSTHESIS (K111097)Fx Solutions2011-11-09
DEPUY GLOBAL AP CTA HUMERAL HEAD (K082715)DePuy Orthopaedics, Inc.2008-12-18
DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER (K080990)DePuy Orthopaedics, Inc.2008-08-08
DVO EXTENDED ARTICULATION HUMERAL HEADS (K073331)Dvo Extremity Solutions, LLC2008-02-19
SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM (K072578)Synthes (Usa)2007-11-28
ASCENSION HUMERAL RESURFACING ARTHOPLASTY (HRA) SYSTEM TPS/HA (K071064)Ascension Orthopedics, Inc.2007-06-22
REUNION HA FRACTURE STEM (K070963)Howmedica Osteonics Corp.2007-05-04
PROMOS MODULAR SHOULDER SYSTEM (K063578)Plus Orthopedics AG2007-03-02
AEQUALIS RESURFACING HEAD (K062661)Tornier2006-12-22
MODULAR REPLACEMENT ELBOW SYSTEM (K062845)Howmedica Osteonics Corp.2006-12-13
AEQUALIS SHOULDER SYSTEM (K063081)Tornier2006-11-09
ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEM (K062861)Ascension Orthopedics, Inc.2006-10-31
AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM (K061862)Axiom Orthopaedics, Inc.2006-08-28
SOLAR PUREFIX HA SHOULDER (K061677)Howmedica Osteonics Corp.2006-07-10
EXACTECH EQUINOXE SHOULDER STEMS (K061454)Exactech, Inc.2006-06-12
SPACER-S TEMPORARY SHOULDER SPACER (K060535)Tecres S.P.A.2006-05-24
COPELAND EAS HUMERAL RESURFACING HEADS (K051843)Biomet, Inc.2005-09-29
SOLAR 2 ANATOMIC SHOULDER (K040432)Stryker Orthopaedics2005-01-07
MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS (K040128)Howmedica Osteonics Corp.2004-03-26
PROMOS SHOULDER (K032126)Plus Orthopedics2004-01-08
DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS (K033516)DePuy Orthopaedics, Inc.2003-12-03
GLOBAL CAP RESURFACING REPLACEMENT SHOULDER (K031971)DePuy Orthopaedics, Inc.2003-09-24
MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEM (K032264)Howmedica Osteonics Corp.2003-08-08
CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM (K023096)Std Mfg., Inc.2003-04-10
OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES (K012377)Corin USA2002-03-11
COPELAND MB/HA RESURFACING HUMERAL HEADS (K010827)Biomet Orthopedics, Inc.2001-09-14
COPELAND MB RESURFACING HUMERAL HEADS (K010657)Biomet Manufacturing, Inc.2001-09-14
AEQUALIS PRESS-FIT SHOULDER PROSTHESIS (K011942)Tornier2001-07-13
COPELAND RESURFACING HUMERAL HEADS (K010664)Biomet Manufacturing, Inc.2001-04-05
COPELAND RESURFACING HEADS (K003044)Biomet, Inc.2000-12-13
ISS OFFSET HEADS (K003428)Biomet, Inc.2000-11-24
SOLAR SHOULDER OFFSET HUMERAL HEAD (K001419)Howmedica Osteonics Corp.2000-07-27
ACUMED MODULAR SHOULDER SYSTEM (K992525)Acu Med, Inc.2000-02-04
BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT (K992394)Endotec, Inc.1999-10-15
HOWMEDICA HUMERAL INTERCALARY SYSTEM (K984202)Howmedica, Inc.1999-02-05
OTI MODULAR SHOULDER SYSTEM (K982886)Osteoimplant Technology, Inc.1998-10-05
KIRSCHNER SHOLDERS WITH TITANIUM PLASMA SPRAY (K961260)Biomet, Inc.1997-04-02
SELECT SHOULDER COCR HUMERAL STEM COMPONENT (K962289)Intermedics Orthopedics1996-08-29
HOWMEDICCA MODULAR PROXIMAL HUMERUS REPLACEMENT SYSTEM (K954559)Howmedica Corp.1996-07-12
INFINITY SHOULDER SYSTEM (K943908)Wrightmedicaltechnologyinc1995-05-30
HEMI-SHOULDER PROSTHESIS (K950594)Encore Orthopedics, Inc.1995-05-22
ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEM (K935593)Biodynamic Technologies, Inc.1994-10-14
LIMA RPS SHOULDER (K913282)Turnkey Intergration USA, Inc.1991-10-21
BONE NAIL, KUNTSCHER (K911982)International Hospital Supply Co.1991-07-26
GLOBAL TOTAL SHOULDER, UNCEMENT HUMERAL HEMI-SHOUL (K911686)Depuy, Inc.1991-07-15
TEMPERLITE(TM) SAW BLADE (K911902)Sierra Surgical, Inc.1991-06-28
TOTAL SHOULDER PROSTHESIS POLYETHYLENE GLENOIND CO (K905580)Exactech, Inc.1991-03-12
EXACTECH HUMERAL SHOULDER PROSTHESIS (K905577)Exactech, Inc.1991-03-12
KIRSCHNER NEER-III MODULAR PROXIMAL HUMERUS (K874643)Kirschner Medical Corp.1988-01-06
SELECT SHOULDER SYSTEM (K873679)Intermedics Orthopedics1987-11-17
KIRSCHNER NEER-III PROXIMAL HUMERUS (K873073)Kirschner Medical Corp.1987-10-01
101 NEER TYPE SHOULDER (K822771)Intermedics Orthopedics1982-10-06
MONOSPHERICAL SHOULDER PROSTHESIS (K802123)Howmedica Corp.1980-09-16
NEW JERSEY HEMIARTHROPLASTY SHOLDER PROS (K800494)Depuy, Inc.1980-03-18
REXTON HS(HEARING SYSTEM) (K791548)Argosy Intl. (Usa), Inc.1979-09-28

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