ClearanceBrief
Panels › Orthopedic › Product code HSD · Class 2

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Regulation 888.3690

0510(k)s in 12 months (71 all time)
0recalls in 12 months (19 all time)
19recalls that name a 510(k)
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Top companies in HSD

Company510(k)sRecalls
Arthrosurface, Inc.25
Howmedica Osteonics Corp.60
Arthrex, Inc.50
DePuy Orthopaedics, Inc.41
Exactech, Inc.41
Biomet, Inc.40
Fx Solutions22
Zimmer GmbH13
Ascension Orthopedics, Inc.21
Howmedica Corp.30
Decided510(k)Device and applicantCode
Feb 12, 2024K233260Univers Revers CA Head and Adapter
Arthrex, Inc.
HSD
May 19, 2022K221232Univers Revers Humeral Cup Implant
Arthrex, Inc.
HSD
Nov 12, 2020K191433AGILON® XO Shoulder Replacement System
Implantcast GmbH, DE
HSD
May 15, 2020K193122Biocore9 Humeral Resurfacing System
Biocore9, LLC
HSD
Apr 18, 2018K173964OVOMotion Shoulder Arthroplasty System
Arthrosurface, Inc.
HSD
Nov 21, 2016K161782Arthrex Univers Revers Shoulder Prosthesis System
Arthrex, Inc.
HSD
Nov 1, 2016K161620Anatomical Shoulder Domelock Dome centric
Zimmer GmbH, CH
HSD
Apr 19, 2016K151527Arthrex Univers Revers CA Heads and Adapters
Arthrex, Inc.
HSD
Dec 19, 2014K142942HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System
Arthrosurface, Inc.
HSD
Nov 26, 2013K131298EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM
Exactech, Inc.
HSD
Nov 9, 2013K130759HUMELOCK II CEMENTLESS SHOULDER SYSTEM
Fx Solutions, FR
HSD
Oct 30, 2013K130675ARTHREX UNIVERS II CA HEADS
Arthrex, Inc.
HSD
Aug 26, 2013K130635SEVIIN SURFACE REPLACEMENT SHOULDER
Ingen Orthopedics, LLC
HSD
Sep 7, 2012K121714SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS
Smith & Nephew, Inc.
HSD
Jun 1, 2012K112900SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS
Lima Corporate S.P.A.
HSD
Dec 12, 2011K112983SPACER-S
Tecres S.P.A.
HSD
Nov 9, 2011K111097HUMELOCK CEMENTED SHOULDER PROSTHESIS
Fx Solutions, FR
HSD
Dec 18, 2008K082715DEPUY GLOBAL AP CTA HUMERAL HEAD
DePuy Orthopaedics, Inc.
HSD
Aug 8, 2008K080990DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER
DePuy Orthopaedics, Inc.
HSD
Feb 19, 2008K073331DVO EXTENDED ARTICULATION HUMERAL HEADS
Dvo Extremity Solutions, LLC
HSD
Nov 28, 2007K072578SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM
Synthes (Usa)
HSD
Jun 22, 2007K071064ASCENSION HUMERAL RESURFACING ARTHOPLASTY (HRA) SYSTEM TPS/HA
Ascension Orthopedics, Inc.
HSD
May 4, 2007K070963REUNION HA FRACTURE STEM
Howmedica Osteonics Corp.
HSD
Mar 2, 2007K063578PROMOS MODULAR SHOULDER SYSTEM
Plus Orthopedics AG
HSD
Dec 22, 2006K062661AEQUALIS RESURFACING HEAD
Tornier, FR
HSD
Dec 13, 2006K062845MODULAR REPLACEMENT ELBOW SYSTEM
Howmedica Osteonics Corp.
HSD
Nov 9, 2006K063081AEQUALIS SHOULDER SYSTEM
Tornier, FR
HSD
Oct 31, 2006K062861ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEM
Ascension Orthopedics, Inc.
HSD
Aug 28, 2006K061862AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM
Axiom Orthopaedics, Inc.
HSD
Jul 10, 2006K061677SOLAR PUREFIX HA SHOULDER
Howmedica Osteonics Corp.
HSD
Jun 12, 2006K061454EXACTECH EQUINOXE SHOULDER STEMS
Exactech, Inc.
HSD
May 24, 2006K060535SPACER-S TEMPORARY SHOULDER SPACER
Tecres S.P.A.
HSD
Sep 29, 2005K051843COPELAND EAS HUMERAL RESURFACING HEADS
Biomet, Inc.
HSD
Jan 7, 2005K040432SOLAR 2 ANATOMIC SHOULDER
Stryker Orthopaedics
HSD
Mar 26, 2004K040128MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS
Howmedica Osteonics Corp.
HSD
Jan 8, 2004K032126PROMOS SHOULDER
Plus Orthopedics
HSD
Dec 3, 2003K033516DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS
DePuy Orthopaedics, Inc.
HSD
Sep 24, 2003K031971GLOBAL CAP RESURFACING REPLACEMENT SHOULDER
DePuy Orthopaedics, Inc.
HSD
Aug 8, 2003K032264MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEM
Howmedica Osteonics Corp.
HSD
Apr 10, 2003K023096CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM
Std Mfg., Inc.
HSD
Mar 11, 2002K012377OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES
Corin USA
HSD
Sep 14, 2001K010827COPELAND MB/HA RESURFACING HUMERAL HEADS
Biomet Orthopedics, Inc.
HSD
Sep 14, 2001K010657COPELAND MB RESURFACING HUMERAL HEADS
Biomet Manufacturing, Inc.
HSD
Jul 13, 2001K011942AEQUALIS PRESS-FIT SHOULDER PROSTHESIS
Tornier, FR
HSD
Apr 5, 2001K010664COPELAND RESURFACING HUMERAL HEADS
Biomet Manufacturing, Inc.
HSD
Dec 13, 2000K003044COPELAND RESURFACING HEADS
Biomet, Inc.
HSD
Nov 24, 2000K003428ISS OFFSET HEADS
Biomet, Inc.
HSD
Jul 27, 2000K001419SOLAR SHOULDER OFFSET HUMERAL HEAD
Howmedica Osteonics Corp.
HSD
Feb 4, 2000K992525ACUMED MODULAR SHOULDER SYSTEM
Acu Med, Inc.
HSD
Oct 15, 1999K992394BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT
Endotec, Inc.
HSD

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