FDA.reportPublic FDA data

Reverse shoulder head prosthesis trial

Definition
A copy of a final reverse shoulder prosthesis head designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient and to ensure its proper orientation and positioning. It is hemisphere-shaped (glenosphere) and typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.
GUDID devices
204
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00889024650596COMP AUG BSPLT TRIAL-GUIDE SMZimmer, Inc.SSI0070002023-01-23
00889024650602COMP AUG BSPLT TRIAL-GUIDE MDZimmer, Inc.SSI0070012023-01-23
00889024650619COMP AUG BSPLT TRIAL-GUIDE LGZimmer, Inc.SSI0070022023-01-23
08033390023504SMR ShoulderLIMACORPORATE SPATrial Glenosphere2016-06-09
08033390023566SMR ShoulderLIMACORPORATE SPATrial Ecc. Glenosphere2016-06-09
08033390098298SMR ShoulderLIMACORPORATE SPATrial Glenosphere2016-06-09
08033390098304SMR ShoulderLIMACORPORATE SPATrial Ecc. Glenosphere2016-06-09
08033390103435SMR ShoulderLIMACORPORATE SPATrial Glenosphere 2016-04-06
08033390103459SMR ShoulderLIMACORPORATE SPATrial Ecc. Glenosphere2016-06-09
08033390109963SMR SHOULDERLIMACORPORATE SPATrial Glenosphere2017-01-11
08033390109970SMR SHOULDERLIMACORPORATE SPATrial Glenosphere2017-01-11
08033390109987SMR SHOULDERLIMACORPORATE SPATrial Glenosphere2017-01-11
08033390113779Trial GlenosphereLIMACORPORATE SPATrial Glenosphere2016-08-05
08033390124089SMR Shoulder - Hybrid GlenoidLIMACORPORATE SPATrial Glenosphere2017-07-05
08033390124096SMR Shoulder - Hybrid GlenoidLIMACORPORATE SPATrial Glenosphere2017-07-05
08033390124119SMR Shoulder - Hybrid GlenoidLIMACORPORATE SPATrial Glenosphere2017-07-05
08033390124126SMR Shoulder - Hybrid GlenoidLIMACORPORATE SPATrial Glenosphere2017-07-05
08033390153683SMR LATERALIZED CONNECTORLIMACORPORATE SPA9013.74.3112019-02-16
08033390153690SMR LATERALIZED CONNECTORLIMACORPORATE SPA9013.74.3152019-02-16
08033390153706SMR LATERALIZED CONNECTORLIMACORPORATE SPA9013.74.3142019-02-16
08033390153713SMR LATERALIZED CONNECTORLIMACORPORATE SPA9013.74.3132019-02-16
08033390153720SMR LATERALIZED CONNECTORLIMACORPORATE SPA9013.74.3122019-02-16
08033390153737SMR LATERALIZED CONNECTORLIMACORPORATE SPA9013.74.3242019-02-16
08033390153744SMR LATERALIZED CONNECTORLIMACORPORATE SPA9013.74.3232019-02-16
08033390153751SMR LATERALIZED CONNECTORLIMACORPORATE SPA9013.74.3222019-02-16
08033390153768SMR LATERALIZED CONNECTORLIMACORPORATE SPA9013.74.3212019-02-16
08033390285933SMR SystemLIMACORPORATE SPA9013.79.5772025-10-29
08033390285940SMR SystemLIMACORPORATE SPA9013.79.5782025-10-29
08033390250474PRIMA TT GlenoidLIMACORPORATE SPA9019.74.0442026-02-19
08033390250481PRIMA TT GlenoidLIMACORPORATE SPA9019.76.0442026-02-19
04048844426088AGILON® XO trial glenosphereimplantcast GmbH780340322020-11-19
04048844426095AGILON® XO trial glenosphereimplantcast GmbH780340402020-11-19
04048844426101AGILON® XO trial glenosphereimplantcast GmbH780340362020-11-19
04048844426118AGILON® XO trial glenosphereimplantcast GmbH780340462020-11-19
04048844426125AGILON® XO trial glenosphereimplantcast GmbH780340502020-11-19
04048844426132AGILON® XO trial cap inverseimplantcast GmbH786332002020-11-19
04048844426149AGILON® XO trial cap inverseimplantcast GmbH786332052020-11-19
04048844426156AGILON® XO trial cap inverseimplantcast GmbH786332102020-11-19
04048844426163AGILON® XO trial cap inverseimplantcast GmbH786336002020-11-19
04048844426170AGILON® XO trial cap inverseimplantcast GmbH786336052020-11-19
04048844426187AGILON® XO trial cap inverseimplantcast GmbH786336102020-11-19
04048844426194AGILON® XO trial cap inverseimplantcast GmbH786340002020-11-19
04048844426200AGILON® XO trial cap inverseimplantcast GmbH786340052020-11-19
04048844426217AGILON® XO trial cap inverseimplantcast GmbH786340102020-11-19
08033390278263ProMade ShoulderLIMACORPORATE SPA9CCA.13.0222025-02-14
08033390282765ProMade ShoulderLIMACORPORATE SPA9CCA.13.0232025-02-14
08033390282772ProMade ShoulderLIMACORPORATE SPA9CCA.13.0242025-02-14
08033390282789ProMade ShoulderLIMACORPORATE SPA9CCA.13.0252025-02-14
00190446832669DJO SURGICALEncore Medical, L.P.804-06-4012024-06-27
00190446832744DJO SURGICALEncore Medical, L.P.804-06-4022024-06-27
00190446832768DJO SURGICALEncore Medical, L.P.804-06-4032024-06-27
10885862634139EquinoxeExactech, Inc.SPI-0079062024-02-02
10885862634146EquinoxeExactech, Inc.SPI-0079082024-02-02
00885556871584AETOS Shoulder SystemSmith & Nephew, Inc.TRL0990-860-3803C2023-02-13
00885556871591AETOS Shoulder SystemSmith & Nephew, Inc.TRL0990-860-3401C2023-02-13
00885556871607AETOS Shoulder SystemSmith & Nephew, Inc.TRL0990-860-3803E2023-02-13
00885556871614AETOS Shoulder SystemSmith & Nephew, Inc.TRL0990-860-4203C2023-02-13
00885556871621AETOS Shoulder SystemSmith & Nephew, Inc.TRL0990-860-4203E2023-02-13
00885556864654Titan Reverse Shoulder SystemSmith & Nephew, Inc.TRL-0960-02E2023-06-17
00885556864692Titan Reverse Shoulder SystemSmith & Nephew, Inc.TRL-0960-05C2023-06-17
08033390254793ProMade ShoulderLIMACORPORATE SPA9CCS.13.4362023-05-10
08033390254823ProMade ShoulderLIMACORPORATE SPA9CCS.13.4402023-05-10
08033390254847ProMade ShoulderLIMACORPORATE SPA9CCS.13.4422023-05-10
08033390254854ProMade ShoulderLIMACORPORATE SPA9CCS.13.6362023-05-10
08033390254861ProMade ShoulderLIMACORPORATE SPA9CCS.13.6402023-05-10
08033390254878ProMade ShoulderLIMACORPORATE SPA9CCS.13.6422023-05-10
00885556811306AETOS Shoulder SystemSmith & Nephew, Inc.TRL0990-860-3800C2023-02-09
00885556811313AETOS Shoulder SystemSmith & Nephew, Inc.TRL0990-860-3800E2023-02-09
00885556811542AETOS Shoulder SystemSmith & Nephew, Inc.TRL0990-860-4200C2023-02-09
00885556811559AETOS Shoulder SystemSmith & Nephew, Inc.TRL0990-860-4200E2023-02-09
00885556864791Titan Reverse Shoulder SystemSmith & Nephew, Inc.TRL-0961-02E-S2023-02-02
00885556864814Titan Reverse Shoulder SystemSmith & Nephew, Inc.TRL-0961-05E-S2023-02-02
08033390240567PRIMA TT GlenoidLIMACORPORATE SPA9019.74.0362022-12-03
08033390240574PRIMA TT GlenoidLIMACORPORATE SPA9019.74.0402022-12-03
08033390240581PRIMA TT GlenoidLIMACORPORATE SPA9019.74.0422022-12-03
08033390241038PRIMA TT GlenoidLIMACORPORATE SPA9019.76.0362022-12-03
08033390241045PRIMA TT GlenoidLIMACORPORATE SPA9019.76.0402022-12-03
08033390241052PRIMA TT GlenoidLIMACORPORATE SPA9019.76.0422022-12-03
10885862086938EquinoxeExactech, Inc.321-01-362022-09-19
10885862086945EquinoxeExactech, Inc.321-01-382022-09-19