Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

FDA product code HSN · 63 cleared devices

Class 2 Orthopedic

Regulation: 21 CFR 888.3110
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-11-23 – 2026-06-16

HSN 2026-06-16

Prophecy Incompass Surgical Planning System

Applicant Wright Medical Technology, Inc. (Stryker)

K number K253159

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HSN 2025-09-03

Kinos Total Ankle System

Applicant Restor3D

K number K252454

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HSN 2025-06-20

Incompass Total Ankle System

Applicant Wright Medical Technology, Inc. (Stryker)

K number K250037

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HSN 2025-05-01

APEX 3D Total Ankle Replacement System

Applicant Paragon 28, Inc.

K number K250641

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HSN 2024-12-02

Hintermann Series H2 Total Ankle System

Applicant Vilex, LLC

K number K240475

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HSN 2024-11-01

Prophecy Surgical Planning System

Applicant Wright Medical Technology, Inc. (Stryker)

K number K241999

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HSN 2024-10-18

Kinos Total Ankle System

Applicant Restor3D

K number K242868

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HSN 2024-07-22

Kinos Total Ankle System

Applicant Restor3D

K number K241482

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HSN 2024-06-24

APEX 3D Total Ankle Replacement System

Applicant Paragon 28, Inc.

K number K240259

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HSN 2024-04-29

restor3d Kinos Axiom Total Ankle System

Applicant Restor3D, Inc.

K number K240591

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HSN 2024-04-23

QUANTUM® Patient Specific Instrumentation (PSI) System

Applicant In2bones Sas

K number K231699

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HSN 2023-11-28

Kinos Axiom Total Ankle System

Applicant Restor3D

K number K232595

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HSN 2023-10-12

Exactech® Vantage® Total Ankle System

Applicant Exactech, Inc.

K number K230717

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HSN 2023-09-11

Vantage® Total Ankle System

Applicant Exactech, Inc.

K number K232002

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HSN 2023-07-17

OPTIX H2 Patient Specific Instrument System

Applicant Vilex, LLC

K number K230462

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HSN 2023-04-06

QUANTUM Patient Specific Instrumentation (PSI) System

Applicant In2bones Sas

K number K230313

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HSN 2023-01-27

Prophecy Preoperative Navigation Alignment System

Applicant Wrightmedicaltechnologyinc

K number K222835

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HSN 2022-11-17

MAVEN™ Patient-Specific Instrumentation

Applicant Paragon 28, Inc.

K number K223227

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HSN 2021-08-11

QUANTUM® Patient Specific Instrumentation (PSI) System

Applicant In2bones Sas

K number K211883

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HSN 2021-03-10

PROPHECY Preoperative Navigation Alignment System

Applicant Wrightmedicaltechnologyinc

K number K202815

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HSN 2021-03-06

Apex 3D Total Ankle Replacement System

Applicant Paragon 28, Inc.

K number K210390

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HSN 2021-01-14

Maven Patient-Specific Instrumentation

Applicant Paragon 28, Inc.

K number K202019

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HSN 2020-11-13

APEX 3D Total Ankle Replacement System

Applicant Paragon 28, Inc.

K number K202373

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HSN 2020-07-10

Paragon 28 APEX 3D Total Ankle Replacement System

Applicant Paragon 28, Inc.

K number K192994

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HSN 2020-06-30

Kinos Axiom Total Ankle System

Applicant Kinos Medical

K number K192778

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HSN 2020-06-29

Cadence Total Ankle System

Applicant Integra LifeSciences Corporation

K number K201507

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HSN 2020-06-08

The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System

Applicant Wrightmedicaltechnologyinc

K number K193067

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HSN 2020-01-29

Quantum® Total Ankle Prosthesis

Applicant In2bones Sas

K number K191380

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HSN 2019-08-22

INFINITY Total Ankle System, INBONE Total Ankle System

Applicant Wrightmedicaltechnologyinc

K number K191393

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HSN 2019-04-01

Vantage Total Ankle Flat Cut Talar Components

Applicant Exactech, Inc.

K number K183343

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HSN 2018-12-18

Integra Salto Total Ankle System

Applicant Ascension Orthopedics

K number K182878

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HSN 2018-08-09

INFINITY Total Ankle System

Applicant Wrightmedicaltechnologyinc

K number K181557

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HSN 2018-07-11

INVISION Total Ankle Revision System

Applicant Wrightmedicaltechnologyinc

K number K180730

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HSN 2018-04-26

INFINITY Total Ankle System

Applicant Wrightmedicaltechnologyinc

K number K172633

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HSN 2017-11-07

Hintermann Series H2 Total Ankle System

Applicant Dt Medtech, LLC

K number K171004

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HSN 2017-09-11

INVISION Total Ankle Revision System

Applicant Wrightmedicaltechnologyinc

K number K171067

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HSN 2017-08-16

PROPHECY INVISION Pre-operative Navigation System

Applicant Wrightmedicaltechnologyinc

K number K170968

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HSN 2017-02-22

PROPHECY INVISION Preoperative Navigation Alignment System

Applicant Wrightmedicaltechnologyinc

K number K162795

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HSN 2016-08-11

Salto XT, Salto Talaris

Applicant Tornier S.A.S.

K number K153452

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HSN 2016-05-06

INVISION Total Ankle Revision System

Applicant Wrightmedicaltechnologyinc

K number K153008

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HSN 2016-03-10

Exactech Vantage Total Ankle System

Applicant Exactech, Inc.

K number K152217

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HSN 2013-07-05

PROPHECY INFINITY PREOPERATIVE NAVIGATION ALIGNMENT GUIDES

Applicant Wrightmedicaltechnologyinc

K number K131283

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HSN 2013-05-17

SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS

Applicant Tornier S.A.S.

K number K130533

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HSN 2013-04-01

INFINITY TOTAL ANKLE SYSTEM

Applicant Wrightmedicaltechnologyinc

K number K123954

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HSN 2013-03-04

INBONE ( I AND II) TOTAL ANKLE SYSTEMS

Applicant Wrightmedicaltechnologyinc

K number K123059

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HSN 2012-10-31

DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS

Applicant DePuy Orthopaedics, Inc.

K number K122395

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HSN 2012-08-24

ZIMMER TRABECULAR METAL TOTAL ANKLE

Applicant Zimmer, Inc.

K number K120906

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HSN 2011-12-16

PROPHECY INBONE PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES

Applicant Wrightmedicaltechnologyinc

K number K110360

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HSN 2010-12-14

INBONE TOTAL ANKLE SYSTEM MODEL 200347902

Applicant Wrightmedicaltechnologyinc

K number K103374

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HSN 2010-08-26

INBONE II TOTAL ANKLE REPLACEMENT

Applicant Wrightmedicaltechnologyinc

K number K100886

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HSN 2009-03-17

SALTO TALARIS TOTAL ANKLE PROSTHESIS

Applicant Tornier

K number K090076

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HSN 2006-11-22

ECLIPSE TOTAL ANKLE IMPLANT

Applicant Kinetikos Medical, Inc.

K number K061749

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HSN 2006-11-13

SALTO TALARIS TOTAL ANKLE PROSTHESIS

Applicant Tornier

K number K060544

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HSN 2006-03-31

AGILITY LP TOTAL ANKLE PROSTHESIS

Applicant DePuy Orthopaedics, Inc.

K number K053569

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HSN 2005-11-15

TOPEZ TOTAL ANKLE REPLACEMENT

Applicant Topez Orthopedics, Inc.

K number K051023

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HSN 2002-05-20

AGILITY ANKLE REVISION PROSTHESIS

Applicant Depuy, Inc.

K number K020541

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HSN 1992-12-17

ALVINE TOTAL ANKLE

Applicant Depuy, Inc.

K number K920802

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HSN 1981-02-19

BRIGHAM TOTAL ANKLE PROSTHESIS

Applicant Howmedica Corp.

K number K803167

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HSN 1980-04-02

SCHLEIN TRI-SURFACE ANKLE

Applicant Orthopedic Equipment Co., Inc.

K number K800530

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HSN 1977-03-14

COMPONENTS, ANKLE, TRIAL, CON-AXIAL

Applicant Depuy, Inc.

K number K770421

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HSN 1977-03-14

FORCEPS, ANKLE INSERTING, CON-AXIAL

Applicant Depuy, Inc.

K number K770420

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HSN 1976-11-23

ANKLE INSTRUMENTS (FREEMAN-SWANSON)

Applicant Medishield, Inc.

K number K761021

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HSN 1976-11-23

ANKLE (FREEMAN-SWANSON)

Applicant Medishield, Inc.

K number K761020

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