FDA.reportPublic FDA data

Shoulder humeral body prosthesis

Definition
A sterile implantable component of a total shoulder prosthesis intended to form a connection between a humeral stem prosthesis and a humeral head prosthesis. It is made of metal [e.g., cobalt-chrome-molybdenum (Co-Cr-Mo)] or titanium (Ti)] and is used in a modular shoulder replacement system.
GUDID devices
309
Last updated
2026-08-28 10:20:02

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00888867306004Arthrex®ARTHREX, INC.AR-9501FTK2021-06-30
03701037300749Humeris ShoulderFX SOLUTIONS112-00302017-05-22
03701037300756Humeris ShoulderFX SOLUTIONS112-00332017-05-22
03701037300763Humeris ShoulderFX SOLUTIONS112-00352017-05-22
00846832092536Tornier Perform Humeral SystemTORNIER, INC.PFX000012022-12-21
00846832092543Tornier Perform Humeral SystemTORNIER, INC.PFX000022022-12-21
00846832092550Tornier Perform Humeral SystemTORNIER, INC.PFX000032022-12-21
00846832094035Tornier HRSTORNIER, INC.ARS10544012024-12-16
00846832094042Tornier HRSTORNIER, INC.ARS10544022024-12-16
00846832094059Tornier HRSTORNIER, INC.ARS10544032024-12-16
04026575234363Embrace Shoulder SystemWALDEMAR LINK GmbH & Co. KG641-040/142023-01-26
04026575234370Embrace Shoulder SystemWALDEMAR LINK GmbH & Co. KG641-040/162023-01-26
04026575234387Embrace Shoulder SystemWALDEMAR LINK GmbH & Co. KG641-040/182023-01-26
04026575234394Embrace Shoulder SystemWALDEMAR LINK GmbH & Co. KG641-045/142023-01-26
04026575234400Embrace Shoulder SystemWALDEMAR LINK GmbH & Co. KG641-045/162023-01-26
04026575234417Embrace Shoulder SystemWALDEMAR LINK GmbH & Co. KG641-045/182023-01-26
04026575234424Embrace Shoulder SystemWALDEMAR LINK GmbH & Co. KG641-050/142023-01-26
04026575234431Embrace Shoulder SystemWALDEMAR LINK GmbH & Co. KG641-050/162023-01-26
04026575234448Embrace Shoulder SystemWALDEMAR LINK GmbH & Co. KG641-050/182023-01-26
04048844330613AGILON® metaphyseal component trauma incl. safety screwimplantcast GmbH382100012020-11-18
04048844330620AGILON® metaphyseal component omarthrosis incl. safety screwimplantcast GmbH382100022020-11-18
04048844330668AGILON® metaphyseal component omarthrosis incl. safety screwimplantcast GmbH382100032020-11-18
04048844330675AGILON® metaphyseal component trauma incl. safety screwimplantcast GmbH382100112020-11-18
04048844330682AGILON® metaphyseal component omarthrosis incl. safety screwimplantcast GmbH382100122020-11-18
04048844330699AGILON® metaphyseal component omarthrosis incl. safety screwimplantcast GmbH382100132020-11-18
04048844399887AGILON® metaphyseal component trauma incl. safety screwimplantcast GmbH382100512020-11-18
04048844399900AGILON® metaphyseal component omarthrosis incl. safety screwimplantcast GmbH382100532020-11-18
04048844399924AGILON® metaphyseal component omarthrosis incl. safety screwimplantcast GmbH382100622020-11-18
04048844399931AGILON® metaphyseal component omarthrosis incl. safety screwimplantcast GmbH382100632020-11-18
04048844399948AGILON® metaphyseal component trauma incl. safety screwimplantcast GmbH382100712020-11-18
04048844399955AGILON® metaphyseal component omarthrosis incl. safety screwimplantcast GmbH382100722020-11-18
04048844400767AGILON® metaphyseal component omarthrosis incl. safety screwimplantcast GmbH382100522020-11-18
04048844400774AGILON® metaphyseal component trauma incl. safety screwimplantcast GmbH382100612020-11-18
04048844400781AGILON® metaphyseal component omarthrosis incl. safety screwimplantcast GmbH382100732020-11-18
04048844422257AGILON® metaphyseal component traumaimplantcast GmbH38210051002020-11-18
04048844422264AGILON® metaphyseal component omarthrosisimplantcast GmbH38210052002020-11-18
04048844422271AGILON® metaphyseal component omarthrosisimplantcast GmbH38210053002020-11-18
04048844422288AGILON® metaphyseal component traumaimplantcast GmbH38210061002020-11-18
04048844422295AGILON® metaphyseal component omarthrosisimplantcast GmbH38210062002020-11-18
04048844422301AGILON® metaphyseal component omarthrosisimplantcast GmbH38210063002020-11-18
04048844422318AGILON® metaphyseal component traumaimplantcast GmbH38210071002020-11-18
04048844422325AGILON® metaphyseal component omarthrosisimplantcast GmbH38210072002020-11-18
04048844422332AGILON® metaphyseal component omarthrosisimplantcast GmbH38210073002020-11-18
04048844422349AGILON® metaphyseal component traumaimplantcast GmbH38210001002020-11-18
04048844422356AGILON® metaphyseal component omarthrosisimplantcast GmbH38210002002020-11-18
04048844422363AGILON® metaphyseal component omarthrosisimplantcast GmbH38210003002020-11-18
04048844426484AGILON® metaphyseal component traumaimplantcast GmbH38210011002020-11-18
04048844426491AGILON® metaphyseal component omarthrosisimplantcast GmbH38210012002020-11-18
04048844426507AGILON® metaphyseal component omarthrosisimplantcast GmbH38210013002020-11-18
08033390002004SMR ShoulderLIMACORPORATE SPAHumeral Body 2015-07-29
08033390002011SMR ShoulderLIMACORPORATE SPAHumeral Body 2015-07-29
08033390002028SMR ShoulderLIMACORPORATE SPAHumeral Body 2015-07-29
08033390002035SMR ShoulderLIMACORPORATE SPAHumeral Body 2015-07-29
08033390272346SMR SystemLIMACORPORATE SPA1350.15.1102024-02-22
08033390272483SMR SystemLIMACORPORATE SPA1350.15.0102024-02-22
08033390272490SMR SystemLIMACORPORATE SPA1350.15.0202024-02-22
08033390272506SMR SystemLIMACORPORATE SPA1350.15.0302024-02-22
10381780123156Titan™ Total Shoulder SystemAscension Orthopedics, Inc.BOD-0923-020-08STD2017-10-09
10381780123170Titan™ Total Shoulder SystemAscension Orthopedics, Inc.BOD-0923-020-10SML2017-10-09
10381780123187Titan™ Total Shoulder SystemAscension Orthopedics, Inc.BOD-0923-020-10STD2017-10-09
10381780123194Titan™ Total Shoulder SystemAscension Orthopedics, Inc.BOD-0923-020-12STD2017-10-09
10381780123217Titan™ Total Shoulder SystemAscension Orthopedics, Inc.BOD-0923-020-14SML2017-10-09
10381780123224Titan™ Total Shoulder SystemAscension Orthopedics, Inc.BOD-0923-020-14STD2017-10-09
10381780123231Titan™ Total Shoulder SystemAscension Orthopedics, Inc.BOD-0923-021-08LRG2017-10-09
10381780123255Titan™ Total Shoulder SystemAscension Orthopedics, Inc.BOD-0923-021-08STD2017-10-09
10885862079381EquinoxeExactech, Inc.300-10-152015-10-30
10885862079398EquinoxeExactech, Inc.300-10-452015-10-30
10885862079480EquinoxeExactech, Inc.300-25-002015-10-30
10885862079497EquinoxeExactech, Inc.300-25-152015-10-30
10885862079503EquinoxeExactech, Inc.300-25-452015-10-30
10885862195975EquinoxeExactech, Inc.300-21-002015-10-30
10885862195982EquinoxeExactech, Inc.300-21-152015-10-30
10885862195999EquinoxeExactech, Inc.300-21-452015-10-30
10885862210807EquinoxeExactech, Inc.300-50-452015-10-30
10885862217974EquinoxeExactech, Inc.300-51-152015-10-30
10885862217981EquinoxeExactech, Inc.300-51-452015-10-30
10885862217998EquinoxeExactech, Inc.300-51-002015-10-30
10886982241313NASYNTHES (U.S.A.) LP5413-20/52015-09-14
10886982241320NASYNTHES (U.S.A.) LP5413-20/5-102015-09-14
10886982241337NASYNTHES (U.S.A.) LP5413-20/5-152015-09-14