FDA.reportPublic FDA data

Metacarpal prosthesis

Definition
A sterile implantable device designed to replace the proximal end (base) of the first metacarpal of the thumb carpometacarpal (CMC) joint (articulation with the trapezium) typically to treat thumb instability/motion disabilities caused by arthritis or fracture. It is typically a one-piece device, made of one or several materials (e.g., carbon, graphite, metal); implantation may be performed with our without bone cement.
GUDID devices
129
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
M685112000ATLASPARCUS MEDICAL LLC112002019-10-07
07640181160013TOUCH® CMC 1Keri Medical SANTO062025-07-18
07640181160020TOUCH® CMC 1Keri Medical SANTO082025-07-18
07640181160037TOUCH® CMC 1Keri Medical SANTO0102025-07-18
07640181160044TOUCH® CMC 1Keri Medical SANTO1562025-07-18
07640181160051TOUCH® CMC 1Keri Medical SANTO1582025-07-18
07640181160068TOUCH® CMC 1Keri Medical SANTO15102025-07-18
07640181160075TOUCH® CMC 1Keri Medical SACTO092025-07-18
07640181160082TOUCH® CMC 1Keri Medical SACTO102025-07-18
07640181160099TOUCH® CMC 1Keri Medical SACTO1092025-07-18
07640181160105TOUCH® CMC 1Keri Medical SACTO1102025-07-18
07640181160112TOUCH® CMC 1Keri Medical SASTO02025-07-18
07640181160129TOUCH® CMC 1Keri Medical SASTO12025-07-18
07640181160136TOUCH® CMC 1Keri Medical SASTO22025-07-18
07640181160143TOUCH® CMC 1Keri Medical SASTO32025-07-18
07640181160150TOUCH® CMC 1Keri Medical SASTO42025-07-18
07640181160228TOUCH® CMC 1Keri Medical SASTOXS2025-07-18
00810063560232Ensemble CMCEnsemble Orthopedics, Inc.Ensemble CMC Trapezium Rasp2025-05-06
00885556830789PyroSphere CMCSmith & Nephew, Inc.PCS-430-50-WW2022-12-22
00885556857748NuGrip CMCSmith & Nephew, Inc.NUG-443-10M2022-12-22
00885556857762NuGrip CMCSmith & Nephew, Inc.NUG-443-20M2022-12-22
00885556857786NuGrip CMCSmith & Nephew, Inc.NUG-443-30L2022-12-22
00885556857809NuGrip CMCSmith & Nephew, Inc.NUG-443-30S2022-12-22
00885556857823NuGrip CMCSmith & Nephew, Inc.NUG-443-40M2022-12-22
00810063560201Ensemble CMCEnsemble Orthopedics, Inc.Ensemble CMC Bump Rasp2023-08-01
00885556830765PyroSphere CMCSmith & Nephew, Inc.PCS-430-30-WW2022-12-22
00885556830772PyroSphere CMCSmith & Nephew, Inc.PCS-430-40-WW2022-12-22
00885556830758PyroSphere CMCSmith & Nephew, Inc.PCS-430-20-WW2022-12-22
00885556830741PyroSphere CMCSmith & Nephew, Inc.PCS-430-10-WW2022-12-22
00885556856956MCP SystemSmith & Nephew, Inc.TRL-100-50P2023-06-19
00885556856949MCP SystemSmith & Nephew, Inc.TRL-100-50D2023-06-17
10381780114536Ascension® PyroHemiSphereAscension Orthopedics, Inc.PHS44010WW2017-10-09
10381780114543Ascension® PyroHemiSphereAscension Orthopedics, Inc.PHS44020WW2017-10-09
10381780114550Ascension® PyroHemiSphereAscension Orthopedics, Inc.PHS44030WW2017-10-09
10381780114567Ascension® PyroHemiSphereAscension Orthopedics, Inc.PHS44040WW2017-10-09
10381780114574Ascension® PyroHemiSphereAscension Orthopedics, Inc.PHS44050WW2017-10-09
00816342024983ATLASPARCUS MEDICAL LLC112002021-12-09
00810063560089Ensemble CMCEnsemble Orthopedics, Inc.Ensemble CMC Implant Holder2021-10-11
00810063560003Ensemble CMCEnsemble Orthopedics, Inc.Ensemble CMC Implant, Size 1412021-03-30
00810063560010Ensemble CMCEnsemble Orthopedics, Inc.Ensemble CMC Implant, Size 1512021-03-30
00810063560027Ensemble CMCEnsemble Orthopedics, Inc.Ensemble CMC Implant, Size 1612021-03-30
00810063560034Ensemble CMCEnsemble Orthopedics, Inc.Ensemble CMC Peripheral Rasp2021-03-30
00810063560041Ensemble CMCEnsemble Orthopedics, Inc.Ensemble CMC Saddle Rasp2021-03-30
00810063560058Ensemble CMCEnsemble Orthopedics, Inc.Ensemble CMC Trial, Size 1412021-03-30
00810063560065Ensemble CMCEnsemble Orthopedics, Inc.Ensemble CMC Trial, Size 1512021-03-30
00810063560072Ensemble CMCEnsemble Orthopedics, Inc.Ensemble CMC Trial, Size 1612021-03-30
00810063560096Ensemble CMCEnsemble Orthopedics, Inc.Ensemble Instrument Tray2021-03-30
10381780114581Ascension® PyroSphereAscension Orthopedics, Inc.PCS43010WW2017-10-09
10381780114598Ascension® PyroSphereAscension Orthopedics, Inc.PCS43020WW2017-10-09
10381780114604Ascension® PyroSphereAscension Orthopedics, Inc.PCS43030WW2017-10-09
10381780114611Ascension® PyroSphereAscension Orthopedics, Inc.PCS43040WW2017-10-09
10381780114628Ascension® PyroSphereAscension Orthopedics, Inc.PCS43050WW2017-10-09
10381780120056Ascension® NuGrip®Ascension Orthopedics, Inc.NUG44310M2017-10-09
10381780120063Ascension® NuGrip®Ascension Orthopedics, Inc.NUG44310S2017-10-09
10381780120070Ascension® NuGrip®Ascension Orthopedics, Inc.NUG44320M2017-10-09
10381780120087Ascension® NuGrip®Ascension Orthopedics, Inc.NUG44320S2017-10-09
10381780120094Ascension® NuGrip®Ascension Orthopedics, Inc.NUG44330L2017-10-09
10381780120100Ascension® NuGrip®Ascension Orthopedics, Inc.NUG44330M2017-10-09
10381780120117Ascension® NuGrip®Ascension Orthopedics, Inc.NUG44330S2017-10-09
10381780120124Ascension® NuGrip®Ascension Orthopedics, Inc.NUG44340L2017-10-09
10381780120131Ascension® NuGrip®Ascension Orthopedics, Inc.NUG44340M2017-10-09
00841506100319StablyxSKELETAL DYNAMICS L.L.C.STABLYX, CMC Implant, Sz. 12015-10-24
00841506100326StablyxSKELETAL DYNAMICS L.L.C.STABLYX, CMC Implant, Sz. 22015-10-24
00841506100333StablyxSKELETAL DYNAMICS L.L.C.STABLYX, CMC Implant, Sz. 32015-10-24
00841506100340StablyxSKELETAL DYNAMICS L.L.C.STABLYX, CMC Implant, Sz. 42015-10-24
00841506100357StablyxSKELETAL DYNAMICS L.L.C.STABLYX, CMC Implant, Sz. 52015-10-24
00841506101361StablyxSKELETAL DYNAMICS L.L.C.Forceps, Bone Holding Small, Ratcheting2015-10-30
00841506102658StablyxSKELETAL DYNAMICS L.L.C.Osteotome, Curved, 3mm2015-10-30
00841506103112StablyxSKELETAL DYNAMICS L.L.C.STABLYX, CMC Impactor2015-10-30
00841506103129StablyxSKELETAL DYNAMICS L.L.C.STABLYX, Metacarpal Rasp, Sz. 12015-10-30
00841506103136StablyxSKELETAL DYNAMICS L.L.C.STABLYX, Metacarpal Rasp, Sz. 22015-10-30
00841506103143StablyxSKELETAL DYNAMICS L.L.C.STABLYX, Metacarpal Rasp, Sz. 32015-10-30
00841506103150StablyxSKELETAL DYNAMICS L.L.C.STABLYX, Metacarpal Rasp, Sz. 42015-10-30
00841506103167StablyxSKELETAL DYNAMICS L.L.C.STABLYX, Metacarpal Rasp, Sz. 52015-10-30
00841506103174StablyxSKELETAL DYNAMICS L.L.C.STABLYX CMC Arthroplasty System2015-10-30
00841506103181StablyxSKELETAL DYNAMICS L.L.C.STABLYX, Trapezial Sizer, Sz. 12015-10-30
00841506103198StablyxSKELETAL DYNAMICS L.L.C.STABLYX, Trapezial Sizer, Sz. 22015-10-30
00841506103204StablyxSKELETAL DYNAMICS L.L.C.STABLYX, Trapezial Sizer, Sz. 32015-10-30
00841506103211StablyxSKELETAL DYNAMICS L.L.C.STABLYX, Trapezial Sizer, Sz. 42015-10-30
00841506103228StablyxSKELETAL DYNAMICS L.L.C.STABLYX, Trapezial Sizer, Sz. 52015-10-30