FDA.report

Coated ankle tibia prosthesis

Definition
A sterile implantable device designed to replace the distal tibia (tibial 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
198
Last updated
2025-09-15 16:41:55

Related Product Codes

CodeDeviceSpecialtyClassDevices
HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2175
NTGProsthesis, Ankle, Uncemented, Non-ConstrainedUnknown323

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
00841731137975Hintermann Series H2 VILEX LLCHT-318012025-09-05
00841731137982Hintermann Series H2 VILEX LLCHT-318212025-09-05
00841731141941Hintermann Series H2 VILEX LLCHT-318312025-09-05
00841731141958Hintermann Series H2 VILEX LLCHT-318022025-09-05
00841731141965Hintermann Series H2 VILEX LLCHT-318222025-09-05
00841731141972Hintermann Series H2 VILEX LLCHT-318322025-09-05
00841731141989Hintermann Series H2 VILEX LLCHT-318032025-09-05
00841731141996Hintermann Series H2 VILEX LLCHT-318232025-09-05
00841731142009Hintermann Series H2 VILEX LLCHT-318332025-09-05
00841731142016Hintermann Series H2 VILEX LLCHT-318042025-09-05
00841731142023Hintermann Series H2 VILEX LLCHT-318242025-09-05
00841731142030Hintermann Series H2 VILEX LLCHT-318342025-09-05
00841731142047Hintermann Series H2 VILEX LLCHT-318052025-09-05
00841731142054Hintermann Series H2 VILEX LLCHT-318252025-09-05
00841731142061Hintermann Series H2 VILEX LLCHT-318352025-09-05
00841731142078Hintermann Series H2 VILEX LLCHT-318062025-09-05
00841731142085Hintermann Series H2 VILEX LLCHT-318262025-09-05
00841731142092Hintermann Series H2 VILEX LLCHT-318362025-09-05
00841731142108Hintermann Series H2 VILEX LLCHT-328012025-09-05
00841731142115Hintermann Series H2 VILEX LLCHT-328212025-09-05
00841731142122Hintermann Series H2 VILEX LLCHT-328312025-09-05
00841731142139Hintermann Series H2 VILEX LLCHT-328022025-09-05
00841731142146Hintermann Series H2 VILEX LLCHT-328222025-09-05
00841731142153Hintermann Series H2 VILEX LLCHT-328322025-09-05
00841731142160Hintermann Series H2 VILEX LLCHT-328032025-09-05
00841731142177Hintermann Series H2 VILEX LLCHT-328232025-09-05
00841731142184Hintermann Series H2 VILEX LLCHT-328332025-09-05
00841731142191Hintermann Series H2 VILEX LLCHT-328042025-09-05
00841731142207Hintermann Series H2 VILEX LLCHT-328242025-09-05
00841731142214Hintermann Series H2 VILEX LLCHT-328342025-09-05
00841731142221Hintermann Series H2 VILEX LLCHT-328052025-09-05
00841731142238Hintermann Series H2 VILEX LLCHT-328252025-09-05
00841731142245Hintermann Series H2 VILEX LLCHT-328352025-09-05
00841731142252Hintermann Series H2 VILEX LLCHT-328062025-09-05
00841731142269Hintermann Series H2 VILEX LLCHT-328262025-09-05
00841731142276Hintermann Series H2 VILEX LLCHT-328362025-09-05
00841731142283Hintermann Series H2 VILEX LLCHT-315012025-09-05
00841731142290Hintermann Series H2 VILEX LLCHT-315032025-09-05
00841731142306Hintermann Series H2 VILEX LLCHT-315042025-09-05
00841731142313Hintermann Series H2 VILEX LLCHT-315052025-09-05
00841731142320Hintermann Series H2 VILEX LLCHT-315062025-09-05
00840097516134Kinos Aeros InstrumentationRestor3d, Inc.5871-1157 2025-05-01
00840097516141Kinos Aeros Total Ankle ReplacementRestor3d, Inc.1832-0010 2025-05-01
00840097516158Kinos Aeros Total Ankle ReplacementRestor3d, Inc.1832-0020 2025-05-01
00840097516165Kinos Aeros Total Ankle ReplacementRestor3d, Inc.1832-0030 2025-05-01
00840097516172Kinos Aeros Total Ankle ReplacementRestor3d, Inc.1832-0031 2025-05-01
00840097516189Kinos Aeros Total Ankle ReplacementRestor3d, Inc.1832-0040 2025-05-01
00840097516196Kinos Aeros Total Ankle ReplacementRestor3d, Inc.1832-0041 2025-05-01
00840097516202Kinos Aeros Total Ankle ReplacementRestor3d, Inc.1832-0050 2025-05-01
00840097516219Kinos Aeros Total Ankle ReplacementRestor3d, Inc.1832-00512025-05-01
00840097516226Kinos Aeros Total Ankle ReplacementRestor3d, Inc.1832-00522025-05-01
00840097516233Kinos Aeros Total Ankle ReplacementRestor3d, Inc.1833-01042025-05-01
00840097516240Kinos Aeros Total Ankle ReplacementRestor3d, Inc.1833-0106 2025-05-01
00840097516257Kinos Aeros Total Ankle ReplacementRestor3d, Inc.1833-02042025-05-01
00840097516264Kinos Aeros Total Ankle ReplacementRestor3d, Inc.1833-02062025-05-01
00840097516271Kinos Aeros Total Ankle ReplacementRestor3d, Inc.1833-02082025-05-01
B095301201Hintermann Series H3Dt Medtech, LLC12024-02-20
B095301202Hintermann Series H3Dt Medtech, LLC12024-02-20
B095301203Hintermann Series H3Dt Medtech, LLC12024-02-20
B095301204Hintermann Series H3Dt Medtech, LLC12024-02-20
B095301205Hintermann Series H3Dt Medtech, LLC12024-02-20
B095301206Hintermann Series H3Dt Medtech, LLC12024-02-20
B095302201Hintermann Series H3Dt Medtech, LLC12019-08-19
B095302202Hintermann Series H3Dt Medtech, LLC12019-08-19
B095302203Hintermann Series H3Dt Medtech, LLC12019-08-19
B095302204Hintermann Series H3Dt Medtech, LLC12019-08-19
B095302205Hintermann Series H3Dt Medtech, LLC12019-08-19
B095302206Hintermann Series H3Dt Medtech, LLC12019-08-19
00840097504360Kinos Axiom Total Ankle ReplacementRestor3d, Inc.1834-00102024-01-18
00840097509174Kinos Axiom Total Ankle ReplacementRestor3d, Inc.1834-01102024-01-18
00840097509181Kinos Axiom Total Ankle ReplacementRestor3d, Inc.1834-00202024-01-18
00840097509198Kinos Axiom Total Ankle ReplacementRestor3d, Inc.1834-01202024-01-18
00840097509204Kinos Axiom Total Ankle ReplacementRestor3d, Inc.1834-00302024-01-18
00840097509211Kinos Axiom Total Ankle ReplacementRestor3d, Inc.1834-01302024-01-18
00840097509228Kinos Axiom Total Ankle ReplacementRestor3d, Inc.1834-00312024-01-18
00840097509235Kinos Axiom Total Ankle ReplacementRestor3d, Inc.1834-01312024-01-18
00840097509242Kinos Axiom Total Ankle ReplacementRestor3d, Inc.1834-00402024-01-18
00840097509259Kinos Axiom Total Ankle ReplacementRestor3d, Inc.1834-01402024-01-18
00840097509266Kinos Axiom Total Ankle ReplacementRestor3d, Inc.1834-00412024-01-18
00840097509273Kinos Axiom Total Ankle ReplacementRestor3d, Inc.1834-01412024-01-18