FDA.reportPublic FDA data

Coated ankle talus prosthesis

Definition
A sterile implantable device designed to replace the proximal talus (talar component) as part of a primary ankle joint replacement or prosthesis revision. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.
GUDID devices
212
Last updated
2026-08-18 06:10:45

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
B095401122Hintermann Series H2Dt Medtech, LLC4011222018-03-21
B095402112Hintermann Series H2Dt Medtech, LLC4021122018-03-21
B095402113Hintermann Series H2Dt Medtech, LLC4021132018-03-21
B095402114Hintermann Series H2Dt Medtech, LLC4021142018-03-21
B095402121Hintermann Series H2Dt Medtech, LLC4021212018-03-21
B095402122Hintermann Series H2Dt Medtech, LLC4021222018-03-21
B095402123Hintermann Series H2Dt Medtech, LLC4021232018-03-21
B095402124Hintermann Series H2Dt Medtech, LLC4021242018-03-21
B095402125Hintermann Series H2Dt Medtech, LLC4021252018-03-21
B095301113Hintermann Series H3Dt Medtech, LLC3011132019-08-19
B095301114Hintermann Series H3Dt Medtech, LLC3011142019-08-19
B095301115Hintermann Series H3Dt Medtech, LLC3011152019-08-19
B095302113Hintermann Series H3Dt Medtech, LLC3021132019-08-20
B095302125Hintermann Series H3Dt Medtech, LLC3021252019-08-20
00841731139436Hintermann Series VILEX LLCHT-4011102025-09-05
00841731139498Hintermann Series VILEX LLCHT-4021102025-09-05
00841731139610Hintermann Series VILEX LLCHT-4021112025-09-05
00841731139627Hintermann Series VILEX LLCHT-4021122025-09-05
00841731139634Hintermann Series VILEX LLCHT-4021132025-09-05
00841731139641Hintermann Series VILEX LLCHT-4021142025-09-05
00841731139658Hintermann Series VILEX LLCHT-4021152025-09-05
00841731139665Hintermann Series VILEX LLCHT-4021162025-09-05
00841731139672Hintermann Series VILEX LLCHT-4011112025-09-05
00841731139689Hintermann Series VILEX LLCHT-4011122025-09-05
00841731139696Hintermann Series VILEX LLCHT-4011132025-09-05
00841731139702Hintermann Series VILEX LLCHT-4011142025-09-05
00841731139719Hintermann Series VILEX LLCHT-4011152025-09-05
00841731139726Hintermann Series VILEX LLCHT-4011162025-09-05
00841731139733Hintermann Series VILEX LLCHT-4021212025-09-05
00841731139740Hintermann Series VILEX LLCHT-4021222025-09-05
00841731139757Hintermann Series VILEX LLCHT-4021232025-09-05
00841731139764Hintermann Series VILEX LLCHT-4021242025-09-05
00841731139771Hintermann Series VILEX LLCHT-4021252025-09-05
00841731139788Hintermann Series VILEX LLCHT-4011212025-09-05
00841731139795Hintermann Series VILEX LLCHT-4011222025-09-05
00841731139801Hintermann Series VILEX LLCHT-4011232025-09-05
00841731139818Hintermann Series VILEX LLCHT-4011242025-09-05
00841731139825Hintermann Series VILEX LLCHT-4011252025-09-05
B095301111Hintermann Series H3Dt Medtech, LLC12019-08-19
B095301112Hintermann Series H3Dt Medtech, LLC12019-08-19
B095301116Hintermann Series H3Dt Medtech, LLC12019-08-19
B095301121Hintermann Series H3Dt Medtech, LLC12019-08-19
B095301122Hintermann Series H3Dt Medtech, LLC12019-08-19
B095301123Hintermann Series H3Dt Medtech, LLC12019-08-19
B095301124Hintermann Series H3Dt Medtech, LLC12019-08-19
B095301125Hintermann Series H3Dt Medtech, LLC12019-08-19
B095302111Hintermann Series H3Dt Medtech, LLC12019-08-19
B095302112Hintermann Series H3Dt Medtech, LLC12019-08-19
B095302114Hintermann Series H3Dt Medtech, LLC12019-08-19
B095302115Hintermann Series H3Dt Medtech, LLC12019-08-19
B095302116Hintermann Series H3Dt Medtech, LLC12019-08-19
B095302121Hintermann Series H3Dt Medtech, LLC12019-08-19
B095302122Hintermann Series H3Dt Medtech, LLC12019-08-19
B095302123Hintermann Series H3Dt Medtech, LLC12019-08-19
B095302124Hintermann Series H3Dt Medtech, LLC12019-08-19
00840097510453Kinos Total Ankle ReplacementRestor3d, Inc.2834-10022024-06-26
00840097510460Kinos Total Ankle ReplacementRestor3d, Inc.2834-10032024-06-26
00840097510477Kinos Total Ankle ReplacementRestor3d, Inc.2834-10042024-06-26
00840097510484Kinos Total Ankle ReplacementRestor3d, Inc.2834-20002024-06-26
00840097510491Kinos Total Ankle ReplacementRestor3d, Inc.2834-20012024-06-26
00840097510507Kinos Total Ankle ReplacementRestor3d, Inc.2834-20022024-06-26
00840097510514Kinos Total Ankle ReplacementRestor3d, Inc.2834-20032024-06-26
00840097510521Kinos Total Ankle ReplacementRestor3d, Inc.2834-20042024-06-26
00840097510330Kinos Total Ankle ReplacementRestor3d, Inc.2833-10002024-06-25
00840097510347Kinos Total Ankle ReplacementRestor3d, Inc.2833-10012024-06-25
00840097510354Kinos Total Ankle ReplacementRestor3d, Inc.2833-10022024-06-25
00840097510378Kinos Total Ankle ReplacementRestor3d, Inc.2833-10042024-06-25
00840097510385Kinos Total Ankle ReplacementRestor3d, Inc.2833-20002024-06-25
00840097510392Kinos Total Ankle ReplacementRestor3d, Inc.2833-20012024-06-25
00840097510408Kinos Total Ankle ReplacementRestor3d, Inc.2833-20022024-06-25
00840097510415Kinos Total Ankle ReplacementRestor3d, Inc.2833-20032024-06-25
00840097510422Kinos Total Ankle ReplacementRestor3d, Inc.2833-20042024-06-25
00840097510439Kinos Total Ankle ReplacementRestor3d, Inc.2834-10002024-06-25
00840097510446Kinos Total Ankle ReplacementRestor3d, Inc.2834-10012024-06-25
00889795128119Patient Specific Talus SpacerParagon 28, Inc.AOPSTSXXXXL-TI2024-03-07
00889795128126Patient Specific Talus SpacerParagon 28, Inc.AOPSTSXXXXN-TI2024-03-07
00889795128133Patient Specific Talus SpacerParagon 28, Inc.AOPSTSXXXXS-TI2024-03-07
00889795128768Patient Specific Talus SpacerParagon 28, Inc.AOPSTT-XXXXS2024-03-07
00889795128775Patient Specific Talus SpacerParagon 28, Inc.AOPSTT-XXXXN2024-03-07
00889795128782Patient Specific Talus SpacerParagon 28, Inc.AOPSTT-XXXXL2024-03-07