FDA.reportPublic FDA data

Fixed-bearing total ankle prosthesis

Definition
A sterile implantable artificial substitute for an ankle joint designed to replace the main articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes tibial and talar components typically with parts made of metal and polyethylene (PE); the PE bearing that articulates the two components is attached or moulded to one of the components. Fixation devices (e.g., screws) for implantation may be included and implantation may be performed with or without bone cement.
GUDID devices
2,649
Last updated
2026-10-21 00:42:15

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00889795151001APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-390-BL10-S2026-10-12
00889795151018APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-390-BL1S-S2026-10-12
00889795151025APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-390-BL1L-S2026-10-12
00889795151032APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-390-BL20-S2026-10-12
00889795151049APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-390-BL2S-S2026-10-12
00889795151056APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-390-BL2L-S2026-10-12
00889795151063APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-390-BL30-S2026-10-12
00889795151070APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-390-BL3S-S2026-10-12
00889795151087APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-390-BL3L-S2026-10-12
00889795151094APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-390-BL40-S2026-10-12
00889795151100APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-390-BL4S-S2026-10-12
00889795151117APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-390-BL4L-S2026-10-12
00889795151124APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-390-BL50-S2026-10-12
00889795151131APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-390-BL5S-S2026-10-12
00889795151148APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-390-BL5L-S2026-10-12
00889795151155APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-390-BL60-S2026-10-12
00889795151162APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-390-BL6S-S2026-10-12
00889795151179APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-390-BL6L-S2026-10-12
00889795151186APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-390-BR10-S2026-10-12
00889795151193APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-390-BR1S-S2026-10-12
00889795151209APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-390-BR1L-S2026-10-12
00889795151216APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-390-BR20-S2026-10-12
00889795151223APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-390-BR2S-S2026-10-12
00889795151230APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-390-BR2L-S2026-10-12
00889795151247APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-390-BR30-S2026-10-12
00889795151254APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-390-BR3S-S2026-10-12
00889795151261APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-390-BR3L-S2026-10-12
00889795151278APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-390-BR40-S2026-10-12
00889795151285APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-390-BR4S-S2026-10-12
00889795151292APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-390-BR4L-S2026-10-12
00889795151308APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-390-BR50-S2026-10-12
00889795151315APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-390-BR5S-S2026-10-12
00889795151322APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-390-BR5L-S2026-10-12
00889795151339APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-390-BR60-S2026-10-12
00889795151346APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-390-BR6S-S2026-10-12
00889795151353APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-390-BR6L-S2026-10-12
00889795151360APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-391-BL10-S2026-10-12
00889795151377APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-391-BL1S-S2026-10-12
00889795151384APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-391-BL1L-S2026-10-12
00889795151391APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-391-BL20-S2026-10-12
00889795151407APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-391-BL2S-S2026-10-12
00889795151414APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-391-BL2L-S2026-10-12
00889795151421APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-391-BL30-S2026-10-12
00889795151438APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-391-BL3S-S2026-10-12
00889795151445APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-391-BL3L-S2026-10-12
00889795151452APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-391-BL40-S2026-10-12
00889795151469APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-391-BL4S-S2026-10-12
00889795151476APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-391-BL4L-S2026-10-12
00889795151483APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-391-BL50-S2026-10-12
00889795151490APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-391-BL5S-S2026-10-12
00889795151506APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-391-BL5L-S2026-10-12
00889795151513APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-391-BL60-S2026-10-12
00889795151520APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-391-BL6S-S2026-10-12
00889795151537APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-391-BL6L-S2026-10-12
00889795151544APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-391-BR10-S2026-10-12
00889795151551APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-391-BR1S-S2026-10-12
00889795151568APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-391-BR1L-S2026-10-12
00889795151575APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-391-BR20-S2026-10-12
00889795151582APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-391-BR2S-S2026-10-12
00889795151599APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-391-BR2L-S2026-10-12
00889795151605APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-391-BR30-S2026-10-12
00889795151612APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-391-BR3S-S2026-10-12
00889795151629APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-391-BR3L-S2026-10-12
00889795151636APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-391-BR40-S2026-10-12
00889795151643APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-391-BR4S-S2026-10-12
00889795151650APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-391-BR4L-S2026-10-12
00889795151667APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-391-BR50-S2026-10-12
00889795151674APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-391-BR5S-S2026-10-12
00889795151681APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-391-BR5L-S2026-10-12
00889795151698APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-391-BR60-S2026-10-12
00889795151704APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-391-BR6S-S2026-10-12
00889795151711APEX 3D Total Ankle Replacement SystemParagon 28, Inc.P11-391-BR6L-S2026-10-12
00885556831892Salto Talaris Total Ankle ProsthesisSmith & Nephew, Inc.LJU225T2022-12-21
00885556841419XT Revision Ankle Replacement SystemSmith & Nephew, Inc.LJV316T2022-12-21
00885556831939Salto Talaris Total Ankle ProsthesisSmith & Nephew, Inc.LJU235T2022-12-21
00885556831946Salto Talaris Total Ankle ProsthesisSmith & Nephew, Inc.LJU236T2022-12-21
00885556831953Salto Talaris Total Ankle ProsthesisSmith & Nephew, Inc.LJU237T2022-12-21
00885556831960Salto Talaris Total Ankle ProsthesisSmith & Nephew, Inc.LJU238T2022-12-21
00885556831977Salto Talaris Total Ankle ProsthesisSmith & Nephew, Inc.LJU245T2022-12-21
00885556831984Salto Talaris Total Ankle ProsthesisSmith & Nephew, Inc.LJU246T2022-12-21