FDA.reportPublic FDA data

Total shoulder prosthesis

Definition
A sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes glenoid and humeral (head and stem) components typically with parts made of metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.
GUDID devices
1,697
Last updated
2026-06-18 06:05:15

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00888912024983DJO SURGICALEncore Medical, L.P.520-38-0142017-08-07
00888912024990DJO SURGICALEncore Medical, L.P.520-38-0182017-08-07
00888912025003DJO SURGICALEncore Medical, L.P.520-38-1182017-08-07
00888912025010DJO SURGICALEncore Medical, L.P.520-42-0202017-08-07
00888912025027DJO SURGICALEncore Medical, L.P.520-42-1162017-08-07
00888912025034DJO SURGICALEncore Medical, L.P.520-46-1162017-08-07
00888912025041DJO SURGICALEncore Medical, L.P.520-46-1202017-08-07
00888912025058DJO SURGICALEncore Medical, L.P.520-50-1182017-08-07
00888912025065DJO SURGICALEncore Medical, L.P.520-50-1222017-08-07
00888912025072DJO SURGICALEncore Medical, L.P.520-50-1262017-08-07
00888912025089DJO SURGICALEncore Medical, L.P.520-54-1182017-08-07
00888912145114DJO SURGICALEncore Medical, L.P.520-42-0162017-08-07
00888912145138DJO SURGICALEncore Medical, L.P.520-42-1202017-08-07
00888912145145DJO SURGICALEncore Medical, L.P.520-46-0162017-08-07
00888912145152DJO SURGICALEncore Medical, L.P.520-46-0202017-08-07
00888912145169DJO SURGICALEncore Medical, L.P.520-46-0242017-08-07
00888912145190DJO SURGICALEncore Medical, L.P.520-46-1242017-08-07
00888912145206DJO SURGICALEncore Medical, L.P.520-50-0182017-08-07
00888912145213DJO SURGICALEncore Medical, L.P.520-50-0222017-08-07
00888912145220DJO SURGICALEncore Medical, L.P.520-50-0262017-08-07
00888912145237DJO SURGICALEncore Medical, L.P.520-54-0182017-08-07
00888912145244DJO SURGICALEncore Medical, L.P.520-54-0222017-08-07
00888912145251DJO SURGICALEncore Medical, L.P.520-54-0262017-08-07
00888912145268DJO SURGICALEncore Medical, L.P.520-54-1222017-08-07
00888912145275DJO SURGICALEncore Medical, L.P.520-54-1262017-08-07
00888912024952DJO SURGICALEncore Medical, L.P.520-01-2422017-08-07
00190446698470DJO SURGICALEncore Medical, L.P.521-09-5422023-07-13
00190446698487DJO SURGICALEncore Medical, L.P.521-09-5462023-07-13
00190446698494DJO SURGICALEncore Medical, L.P.521-09-5502023-07-13
00190446698500DJO SURGICALEncore Medical, L.P.521-09-5542023-07-13
00190446698517DJO SURGICALEncore Medical, L.P.521-09-6422023-07-13
00190446698524DJO SURGICALEncore Medical, L.P.521-09-6462023-07-13
00190446698531DJO SURGICALEncore Medical, L.P.521-09-6502023-07-13
00190446698548DJO SURGICALEncore Medical, L.P.521-09-6542023-07-13
00190446698555DJO SURGICALEncore Medical, L.P.521-09-7422023-07-13
00190446698562DJO SURGICALEncore Medical, L.P.521-09-7462023-07-13
00190446698579DJO SURGICALEncore Medical, L.P.521-09-7502023-07-13
00190446698586DJO SURGICALEncore Medical, L.P.521-09-7542023-07-13
00190446698593DJO SURGICALEncore Medical, L.P.521-09-8422023-07-13
00190446698609DJO SURGICALEncore Medical, L.P.521-09-8462023-07-13
00190446698616DJO SURGICALEncore Medical, L.P.521-09-8502023-07-13
00190446698623DJO SURGICALEncore Medical, L.P.521-09-8542023-07-13
00888867059931Arthrex®ARTHREX, INC.AR-9301-022025-10-16
03661489673603ARROW®FOURNITURES HOSPITALIERES INDUSTRIE267360 - HUMERAL STEM, Ø6 L1002015-12-21
03661489673610ARROW®FOURNITURES HOSPITALIERES INDUSTRIE267361 - HUMERAL STEM, Ø16 L1402015-12-21
03701037301814FX SolutionsFX SOLUTIONSPRCT2 SIZE 08 CEMENTLESS2016-06-09
03701037301821FX SolutionsFX SOLUTIONSSIZE 09 CEMENTLESS PRCT22016-06-09
03701037303153FX SolutionsFX SOLUTIONS8 HOLES2016-06-08
04048844400071AGILON® XO PE-insert for inverse cap implantcast GmbH386350322020-11-18
04048844400088AGILON® XO PE-insert for inverse cap implantcast GmbH386350362020-11-18
04048844400095AGILON® XO PE-insert for inverse cap implantcast GmbH386350402020-11-18
04048844419233AGILON® XO retentive PE-insert for inverse capimplantcast GmbH386351362020-11-18
04048844419240AGILON® XO retentive PE-insert for inverse capimplantcast GmbH386351402020-11-18
04048844433031AGILON® XO retentive PE-insert for inverse capimplantcast GmbH386351322020-11-18
B1132R1Y2400100Shoulder Innovations Inset Reverse Total ShoulderShoulder Innovations, Inc.Glenoid Baseplate - Classic - TPS - Ø24mm x 0° x 12025-10-07
B1132R1Y2400250Shoulder Innovations Inset Reverse Total ShoulderShoulder Innovations, Inc.Glenoid Baseplate - Classic - TPS - Ø24mm x 0° x 22025-10-07
B1132R1Y2405100Shoulder Innovations Inset Reverse Total ShoulderShoulder Innovations, Inc.Glenoid Baseplate - Classic - TPS - Ø24mm x 5° x 12025-10-07
B1132R1Y2405250Shoulder Innovations Inset Reverse Total ShoulderShoulder Innovations, Inc.Glenoid Baseplate - Classic - TPS - Ø24mm x 0° x 22025-10-07
B1132R1Y2410100Shoulder Innovations Inset Reverse Total ShoulderShoulder Innovations, Inc.Glenoid Baseplate - Classic - TPS - Ø24mm x 10° x 2025-10-07
B1132R1Y2410250Shoulder Innovations Inset Reverse Total ShoulderShoulder Innovations, Inc.Glenoid Baseplate - Classic - TPS - Ø24mm x 10° x 2025-10-07
B1132R1Y2415100Shoulder Innovations Inset Reverse Total ShoulderShoulder Innovations, Inc.Glenoid Baseplate - Classic - TPS - Ø24mm x 15° x 2025-10-07
B1132R1Y2415250Shoulder Innovations Inset Reverse Total ShoulderShoulder Innovations, Inc.Glenoid Baseplate - Classic - TPS - Ø24mm x 15° x 2025-10-07
B1132R1Z2400100Shoulder Innovations Inset Reverse Total ShoulderShoulder Innovations, Inc.Glenoid Baseplate - Standard - TPS - Ø24mm x 0° x 2025-10-07
B1132R1Z2400150Shoulder Innovations Inset Reverse Total ShoulderShoulder Innovations, Inc.Glenoid Baseplate - Standard - TPS - Ø24mm x 0° x 2025-10-07
B1132R1Z2400250Shoulder Innovations Inset Reverse Total ShoulderShoulder Innovations, Inc.Glenoid Baseplate - Standard - TPS - Ø24mm x 0° x 2025-10-07
B1132R1Z2405100Shoulder Innovations Inset Reverse Total ShoulderShoulder Innovations, Inc.Glenoid Baseplate - Standard - TPS - Ø24mm x 5° x 2025-10-07
B1132R1Z2405150Shoulder Innovations Inset Reverse Total ShoulderShoulder Innovations, Inc.Glenoid Baseplate - Standard - TPS - Ø24mm x 5° x 2025-10-07
B1132R1Z2405250Shoulder Innovations Inset Reverse Total ShoulderShoulder Innovations, Inc. Glenoid Baseplate - Standard - TPS - Ø24mm x 5° x2025-10-07
B1132R1Z2410100Shoulder Innovations Inset Reverse Total ShoulderShoulder Innovations, Inc.Glenoid Baseplate - Standard - TPS - Ø24mm x 10° x2025-10-07
B1132R1Z2410150Shoulder Innovations Inset Reverse Total ShoulderShoulder Innovations, Inc.Glenoid Baseplate - Standard - TPS - Ø24mm x 10° x2025-10-07
B1132R1Z2410250Shoulder Innovations Inset Reverse Total ShoulderShoulder Innovations, Inc.Glenoid Baseplate - Standard - TPS - Ø24mm x 10° x2025-10-07
B1132R1Z2415100Shoulder Innovations Inset Reverse Total ShoulderShoulder Innovations, Inc.Glenoid Baseplate - Standard - TPS - Ø24mm x 15° x2025-10-07
B1132R1Z2415150Shoulder Innovations Inset Reverse Total ShoulderShoulder Innovations, Inc.Glenoid Baseplate - Standard - TPS - Ø24mm x 15° x2025-10-07
B1132R1Z2415250Shoulder Innovations Inset Reverse Total ShoulderShoulder Innovations, Inc.Glenoid Baseplate - Standard - TPS - Ø24mm x 15° x2025-10-07
B1132R2GB000100Shoulder Innovations Inset Reverse Total ShoulderShoulder Innovations, Inc.Glenoid Baseplate Stopdrill - Classic TPS - Ø10.762025-10-07
B1132R2GB100100Shoulder Innovations Inset Reverse Total ShoulderShoulder Innovations, Inc.Glenoid Baseplate Stopdrill - Classic Grit Blasted2025-10-07
B1132R2GB101250Shoulder Innovations Inset Reverse Total ShoulderShoulder Innovations, Inc.Glenoid Baseplate Stopdrill - Standard Grit Blaste2025-10-07
B1132R2GB200100Shoulder Innovations Inset Reverse Total ShoulderShoulder Innovations, Inc.Glenoid Baseplate Stopdrill - Standard TPS - Ø10.72025-10-07
B1132R2GB200150Shoulder Innovations Inset Reverse Total ShoulderShoulder Innovations, Inc.Glenoid Baseplate Stopdrill - Standard TPS - Ø10.72025-10-07
B1132R2GB200250Shoulder Innovations Inset Reverse Total ShoulderShoulder Innovations, Inc.Glenoid Baseplate Stopdrill - Standard TPS - Ø10.72025-10-07