Orthopedic

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

Orthopedic · 21 CFR 888.3110 · Class 2

Overview

Product CodeHSN
Device NameProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Regulation21 CFR 888.3110
Device ClassClass 2
Review PanelOrthopedic
ImplantYes

Identification

An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Classification Rationale

Class II.

Cleared Devices (67)

RecordDevice NameApplicantDecision DateDecision
K252454Kinos Total Ankle SystemRestor3DSep 3, 2025SESE
K250037Incompass Total Ankle SystemWright Medical Technology, Inc. (Stryker)Jun 20, 2025SESE
K250641APEX 3D Total Ankle Replacement SystemParagon 28, Inc.May 1, 2025SESE
K240475Hintermann Series H2 Total Ankle SystemVilex, LLCDec 2, 2024SESE
K241999Prophecy Surgical Planning SystemWright Medical Technology, Inc. (Stryker)Nov 1, 2024SESE
K242868Kinos Total Ankle SystemRestor3DOct 18, 2024SESE
K241482Kinos Total Ankle SystemRestor3DJul 22, 2024SESE
K240259APEX 3D Total Ankle Replacement SystemParagon 28, Inc.Jun 24, 2024SESE
K240591restor3d Kinos Axiom Total Ankle SystemRestor3D, Inc.Apr 29, 2024SESE
K231699QUANTUM® Patient Specific Instrumentation (PSI) SystemIn2bones SasApr 23, 2024SESE
K232595Kinos Axiom Total Ankle SystemRestor3DNov 28, 2023SESE
K230717Exactech® Vantage® Total Ankle SystemExactech, Inc.Oct 12, 2023SESE
K232002Vantage® Total Ankle SystemExactech, Inc.Sep 11, 2023SESE
K230462OPTIX H2 Patient Specific Instrument SystemVilex, LLCJul 17, 2023SESE
K230313QUANTUM Patient Specific Instrumentation (PSI) SystemIn2bones SasApr 6, 2023SESE
K222835Prophecy Preoperative Navigation Alignment SystemWrightmedicaltechnologyincJan 27, 2023SESE
K223227MAVEN™ Patient-Specific InstrumentationParagon 28, Inc.Nov 17, 2022SESE
K211883QUANTUM® Patient Specific Instrumentation (PSI) SystemIn2bones SasAug 11, 2021SESE
K202815PROPHECY Preoperative Navigation Alignment SystemWrightmedicaltechnologyincMar 10, 2021SESE
K210390Apex 3D Total Ankle Replacement SystemParagon 28, Inc.Mar 6, 2021SESE
K202019Maven Patient-Specific InstrumentationParagon 28, Inc.Jan 14, 2021SESE
K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.Nov 13, 2020SESE
K192994Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc.Jul 10, 2020SESE
K192778Kinos Axiom Total Ankle SystemKinos MedicalJun 30, 2020SESE
K201507Cadence Total Ankle SystemIntegra LifeSciences CorporationJun 29, 2020SESE
K193067The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision SystemWrightmedicaltechnologyincJun 8, 2020SESE
K191380Quantum® Total Ankle ProsthesisIn2bones SasJan 29, 2020SESE
K191393INFINITY Total Ankle System, INBONE Total Ankle SystemWrightmedicaltechnologyincAug 22, 2019SESE
K183343Vantage Total Ankle Flat Cut Talar ComponentsExactech, Inc.Apr 1, 2019SESE
K182878Integra Salto Total Ankle SystemAscension OrthopedicsDec 18, 2018SESE
K181557INFINITY Total Ankle SystemWrightmedicaltechnologyincAug 9, 2018SESE
K180730INVISION Total Ankle Revision SystemWrightmedicaltechnologyincJul 11, 2018SESE
K172633INFINITY Total Ankle SystemWrightmedicaltechnologyincApr 26, 2018SESE
K171004Hintermann Series H2 Total Ankle SystemDt Medtech, LLCNov 7, 2017SESE
K171067INVISION Total Ankle Revision SystemWrightmedicaltechnologyincSep 11, 2017SESE
K170968PROPHECY INVISION Pre-operative Navigation SystemWrightmedicaltechnologyincAug 16, 2017SESE
K162795PROPHECY INVISION Preoperative Navigation Alignment SystemWrightmedicaltechnologyincFeb 22, 2017SESE
K153452Salto XT, Salto TalarisTornier S.A.S.Aug 11, 2016SESE
K153008INVISION Total Ankle Revision SystemWrightmedicaltechnologyincMay 6, 2016SESE
K152217Exactech Vantage Total Ankle SystemExactech, Inc.Mar 10, 2016SESE
K151459Integra Total Ankle Replacement SystemAscension OrthopedicsAug 31, 2015SESE
K142117INVISION TOTAL ANKLE REVISION SYSTEMWrightmedicaltechnologyincMar 25, 2015SESE
K141740INFINITY (TM) TOTAL ANKLE SYSTEM; INBONE TOTAL ANKLE SYSTEMWrightmedicaltechnologyincMar 5, 2015SESE
K140749INFINITY TOTAL ANKLE SYSTEMWrightmedicaltechnologyincApr 25, 2014SESE
K133585INBONE TOTAL ANKLEWrightmedicaltechnologyincFeb 20, 2014SESE
K131283PROPHECY INFINITY PREOPERATIVE NAVIGATION ALIGNMENT GUIDESWrightmedicaltechnologyincJul 5, 2013SESE
K130533SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHSTornier S.A.S.May 17, 2013SESE
K123954INFINITY TOTAL ANKLE SYSTEMWrightmedicaltechnologyincApr 1, 2013SESE
K123059INBONE ( I AND II) TOTAL ANKLE SYSTEMSWrightmedicaltechnologyincMar 4, 2013SESE
K122395DEPUY AGILITY LP TOTAL ANKLE PROSTHESISDePuy Orthopaedics, Inc.Oct 31, 2012SESE
K120906ZIMMER TRABECULAR METAL TOTAL ANKLEZimmer, Inc.Aug 24, 2012SESE
K110360PROPHECY INBONE PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDESWrightmedicaltechnologyincDec 16, 2011SESE
K103374INBONE TOTAL ANKLE SYSTEM MODEL 200347902WrightmedicaltechnologyincDec 14, 2010SESE
K100886INBONE II TOTAL ANKLE REPLACEMENTWrightmedicaltechnologyincAug 26, 2010SESE
K090076SALTO TALARIS TOTAL ANKLE PROSTHESISTornierMar 17, 2009SESE
K061749ECLIPSE TOTAL ANKLE IMPLANTKinetikos Medical, Inc.Nov 22, 2006SESE
K060544SALTO TALARIS TOTAL ANKLE PROSTHESISTornierNov 13, 2006SESE
K053569AGILITY LP TOTAL ANKLE PROSTHESISDePuy Orthopaedics, Inc.Mar 31, 2006SESE
K051023TOPEZ TOTAL ANKLE REPLACEMENTTopez Orthopedics, Inc.Nov 15, 2005SESE
K020541AGILITY ANKLE REVISION PROSTHESISDepuy, Inc.May 20, 2002SESE
K920802ALVINE TOTAL ANKLEDepuy, Inc.Dec 17, 1992SN
K803167BRIGHAM TOTAL ANKLE PROSTHESISHowmedica Corp.Feb 19, 1981SESE
K800530SCHLEIN TRI-SURFACE ANKLEOrthopedic Equipment Co., Inc.Apr 2, 1980SESE
K770421COMPONENTS, ANKLE, TRIAL, CON-AXIALDepuy, Inc.Mar 14, 1977SESE
K770420FORCEPS, ANKLE INSERTING, CON-AXIALDepuy, Inc.Mar 14, 1977SESE
K761021ANKLE INSTRUMENTS (FREEMAN-SWANSON)Medishield, Inc.Nov 23, 1976SESE
K761020ANKLE (FREEMAN-SWANSON)Medishield, Inc.Nov 23, 1976SESE

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