FDA 510(k) Applications for Medical Device Product Code "HSD"
(Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K992525 | ACUMED, INC. | ACUMED MODULAR SHOULDER SYSTEM | 02/04/2000 |
| K221232 | Arthrex Inc. | Univers Revers Humeral Cup Implant | 05/19/2022 |
| K130675 | ARTHREX, INC. | ARTHREX UNIVERS II CA HEADS | 10/30/2013 |
| K151527 | ARTHREX, INC. | Arthrex Univers Revers CA Heads and Adapters | 04/19/2016 |
| K161782 | ARTHREX, INC. | Arthrex Univers Revers Shoulder Prosthesis System | 11/21/2016 |
| K142942 | ARTHROSURFACE INC. | HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System | 12/19/2014 |
| K173964 | Arthrosurface, Inc. | OVOMotion Shoulder Arthroplasty System | 04/18/2018 |
| K071064 | ASCENSION ORTHOPEDICS, INC. | ASCENSION HUMERAL RESURFACING ARTHOPLASTY (HRA) SYSTEM TPS/HA | 06/22/2007 |
| K062861 | ASCENSION ORTHOPEDICS, INC. | ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEM | 10/31/2006 |
| K061862 | AXIOM ORTHOPAEDICS, INC. | AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM | 08/28/2006 |
| K193122 | Biocore9, LLC. | Biocore9 Humeral Resurfacing System | 05/15/2020 |
| K010657 | BIOMET MANUFACTURING, INC. | COPELAND MB RESURFACING HUMERAL HEADS | 09/14/2001 |
| K010664 | BIOMET MANUFACTURING, INC. | COPELAND RESURFACING HUMERAL HEADS | 04/05/2001 |
| K010827 | BIOMET ORTHOPEDICS, INC. | COPELAND MB/HA RESURFACING HUMERAL HEADS | 09/14/2001 |
| K051843 | BIOMET, INC. | COPELAND EAS HUMERAL RESURFACING HEADS | 09/29/2005 |
| K003044 | BIOMET, INC. | COPELAND RESURFACING HEADS | 12/13/2000 |
| K003428 | BIOMET, INC. | ISS OFFSET HEADS | 11/24/2000 |
| K961260 | BIOMET, INC. | KIRSCHNER SHOLDERS WITH TITANIUM PLASMA SPRAY | 04/02/1997 |
| K012377 | CORIN U.S.A. | OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES | 03/11/2002 |
| K082715 | DEPUY ORTHOPAEDICS, INC. | DEPUY GLOBAL AP CTA HUMERAL HEAD | 12/18/2008 |
| K080990 | DEPUY ORTHOPAEDICS, INC. | DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER | 08/08/2008 |
| K033516 | DEPUY ORTHOPAEDICS, INC. | DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS | 12/03/2003 |
| K031971 | DEPUY ORTHOPAEDICS, INC. | GLOBAL CAP RESURFACING REPLACEMENT SHOULDER | 09/24/2003 |
| K073331 | DVO EXTREMITY SOLUTIONS, LLC | DVO EXTENDED ARTICULATION HUMERAL HEADS | 02/19/2008 |
| K992394 | ENDOTEC, INC. | BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT | 10/15/1999 |
| K131298 | EXACTECH, INC. | EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM | 11/26/2013 |
| K061454 | EXACTECH, INC. | EXACTECH EQUINOXE SHOULDER STEMS | 06/12/2006 |
| K111097 | FX SOLUTIONS | HUMELOCK CEMENTED SHOULDER PROSTHESIS | 11/09/2011 |
| K130759 | FX SOLUTIONS | HUMELOCK II CEMENTLESS SHOULDER SYSTEM | 11/09/2013 |
| K954559 | HOWMEDICA CORP. | HOWMEDICCA MODULAR PROXIMAL HUMERUS REPLACEMENT SYSTEM | 07/12/1996 |
| K040128 | HOWMEDICA OSTEONICS CORP | MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS | 03/26/2004 |
| K070963 | HOWMEDICA OSTEONICS CORP | REUNION HA FRACTURE STEM | 05/04/2007 |
| K061677 | HOWMEDICA OSTEONICS CORP | SOLAR PUREFIX HA SHOULDER | 07/10/2006 |
| K062845 | HOWMEDICA OSTEONICS CORP. | MODULAR REPLACEMENT ELBOW SYSTEM | 12/13/2006 |
| K032264 | HOWMEDICA OSTEONICS CORP. | MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEM | 08/08/2003 |
| K001419 | HOWMEDICA OSTEONICS CORP. | SOLAR SHOULDER OFFSET HUMERAL HEAD | 07/27/2000 |
| K984202 | HOWMEDICA, INC. | HOWMEDICA HUMERAL INTERCALARY SYSTEM | 02/05/1999 |
| K191433 | Implantcast GmbH | AGILON« XO Shoulder Replacement System | 11/12/2020 |
| K130635 | INGEN ORTHOPEDICS LLC | SEVIIN SURFACE REPLACEMENT SHOULDER | 08/26/2013 |
| K962289 | INTERMEDICS ORTHOPEDICS | SELECT SHOULDER COCR HUMERAL STEM COMPONENT | 08/29/1996 |
| K112900 | LIMACORPORATE S.P.A. | SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS | 06/01/2012 |
| K982886 | OSTEOIMPLANT TECHNOLOGY, INC. | OTI MODULAR SHOULDER SYSTEM | 10/05/1998 |
| K032126 | PLUS ORTHOPEDICS | PROMOS SHOULDER | 01/08/2004 |
| K063578 | PLUS ORTHOPEDICS AG | PROMOS MODULAR SHOULDER SYSTEM | 03/02/2007 |
| K121714 | SMITH & NEPHEW, INC. | SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS | 09/07/2012 |
| K023096 | STD MFG., INC. | CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM | 04/10/2003 |
| K040432 | STRYKER ORTHOPAEDICS | SOLAR 2 ANATOMIC SHOULDER | 01/07/2005 |
| K072578 | SYNTHES (USA) | SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM | 11/28/2007 |
| K112983 | TECRES SPA | SPACER-S | 12/12/2011 |
| K060535 | TECRES SPA | SPACER-S TEMPORARY SHOULDER SPACER | 05/24/2006 |
| K011942 | TORNIER | AEQUALIS PRESS-FIT SHOULDER PROSTHESIS | 07/13/2001 |
| K062661 | TORNIER | AEQUALIS RESURFACING HEAD | 12/22/2006 |
| K063081 | TORNIER | AEQUALIS SHOULDER SYSTEM | 11/09/2006 |
| K161620 | ZIMMER GMBH | Anatomical Shoulder Domelock Dome centric | 11/01/2016 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
