BEUDAMED
    Product Code: HSN FDA class 2 21 CFR 888.3110

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

    Orthopedic

    A semi-constrained, cemented, metal/polymer ankle prosthesis is a total ankle replacement implant used to restore joint function in patients with end-stage ankle arthritis, consisting of metallic and polymer components fixed with bone cement. It is classified as an FDA Class 2 device under 21 CFR 888.3110, indicating moderate risk and requiring 510(k) premarket clearance. Product code HSN falls under the Orthopedic medical specialty. This device is an implant.

    View on FDA
    510(k)s
    68
    FEI Numbers
    92
    Registration Numbers
    92
    Unique Applicants
    22
    Years Active
    50

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    Basic Information

    Product Code
    HSN
    Device Class
    FDA class 2
    Regulation Number
    888.3110
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 68 510(k) clearances via K numbers.

    K Number Device Name
    K253159 Prophecy Incompass Surgical Planning System
    K252454 Kinos Total Ankle System
    K250037 Incompass Total Ankle System
    K250641 APEX 3D Total Ankle Replacement System
    K240475 Hintermann Series H2 Total Ankle System
    K241999 Prophecy Surgical Planning System
    K242868 Kinos Total Ankle System
    K241482 Kinos Total Ankle System
    K240259 APEX 3D Total Ankle Replacement System
    K240591 restor3d Kinos Axiom Total Ankle System
    K231699 QUANTUM® Patient Specific Instrumentation (PSI) System
    K232595 Kinos Axiom Total Ankle System
    K230717 Exactech® Vantage® Total Ankle System
    K232002 Vantage® Total Ankle System
    K230462 OPTIX H2 Patient Specific Instrument System
    K230313 QUANTUM Patient Specific Instrumentation (PSI) System
    K222835 Prophecy Preoperative Navigation Alignment System
    K223227 MAVEN™ Patient-Specific Instrumentation
    K211883 QUANTUM® Patient Specific Instrumentation (PSI) System
    K202815 PROPHECY Preoperative Navigation Alignment System
    K210390 Apex 3D Total Ankle Replacement System
    K202019 Maven Patient-Specific Instrumentation
    K202373 APEX 3D Total Ankle Replacement System
    K192994 Paragon 28 APEX 3D Total Ankle Replacement System
    K192778 Kinos Axiom Total Ankle System
    K201507 Cadence Total Ankle System
    K193067 The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System
    K191380 Quantum® Total Ankle Prosthesis
    K191393 INFINITY Total Ankle System, INBONE Total Ankle System
    K183343 Vantage Total Ankle Flat Cut Talar Components
    K182878 Integra Salto Total Ankle System
    K181557 INFINITY Total Ankle System
    K180730 INVISION Total Ankle Revision System
    K172633 INFINITY Total Ankle System
    K171004 Hintermann Series H2 Total Ankle System
    K171067 INVISION Total Ankle Revision System
    K170968 PROPHECY INVISION Pre-operative Navigation System
    K162795 PROPHECY INVISION Preoperative Navigation Alignment System
    K153452 Salto XT, Salto Talaris
    K153008 INVISION Total Ankle Revision System
    K152217 Exactech Vantage Total Ankle System
    K151459 Integra Total Ankle Replacement System
    K142117 INVISION TOTAL ANKLE REVISION SYSTEM
    K141740 INFINITY (TM) TOTAL ANKLE SYSTEM; INBONE TOTAL ANKLE SYSTEM
    K140749 INFINITY TOTAL ANKLE SYSTEM
    K133585 INBONE TOTAL ANKLE
    K131283 PROPHECY INFINITY PREOPERATIVE NAVIGATION ALIGNMENT GUIDES
    K130533 SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS
    K123954 INFINITY TOTAL ANKLE SYSTEM
    K123059 INBONE ( I AND II) TOTAL ANKLE SYSTEMS
    K122395 DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS
    K120906 ZIMMER TRABECULAR METAL TOTAL ANKLE
    K110360 PROPHECY INBONE PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES
    K103374 INBONE TOTAL ANKLE SYSTEM MODEL 200347902
    K100886 INBONE II TOTAL ANKLE REPLACEMENT
    K090076 SALTO TALARIS TOTAL ANKLE PROSTHESIS
    K061749 ECLIPSE TOTAL ANKLE IMPLANT
    K060544 SALTO TALARIS TOTAL ANKLE PROSTHESIS
    K053569 AGILITY LP TOTAL ANKLE PROSTHESIS
    K051023 TOPEZ TOTAL ANKLE REPLACEMENT
    K020541 AGILITY ANKLE REVISION PROSTHESIS
    K920802 ALVINE TOTAL ANKLE
    K803167 BRIGHAM TOTAL ANKLE PROSTHESIS
    K800530 SCHLEIN TRI-SURFACE ANKLE
    K770421 COMPONENTS, ANKLE, TRIAL, CON-AXIAL
    K770420 FORCEPS, ANKLE INSERTING, CON-AXIAL
    K761021 ANKLE INSTRUMENTS (FREEMAN-SWANSON)
    K761020 ANKLE (FREEMAN-SWANSON)

    FEI Numbers

    This FDA classification entry is associated with 92 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 92 registration numbers. Click on an entry to view related FDA registrations.