BEUDAMED
    Product Code: HRY FDA class 2 21 CFR 888.3530

    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

    Orthopedic

    A femorotibial knee prosthesis of the semi-constrained, cemented, metal/polymer type is a total or partial knee replacement implant used to resurface and replace the articulating surfaces of the femur and tibia when damaged by disease or injury. It is classified as an FDA Class 2 device under 21 CFR 888.3530, indicating moderate risk and requiring 510(k) premarket clearance. Product code HRY falls under the Orthopedic medical specialty. This device is an implant.

    View on FDA
    510(k)s
    91
    FEI Numbers
    127
    Registration Numbers
    127
    Unique Applicants
    44
    Years Active
    44

    Basic Information

    Product Code
    HRY
    Device Class
    FDA class 2
    Regulation Number
    888.3530
    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 91 510(k) clearances via K numbers.

    K Number Device Name
    K193549 SIGMA High Performance (HP) Partial Knee System
    K190633 NanoOrtho NanoKnee® System
    K152631 MPO Total Knee Systems MR Labeling
    K150410 RESTORIS POROUS PARTIAL KNEE SYSTEM
    K133940 OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)
    K131167 UNIVATION
    K122277 OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM
    K110415 SIGNATURE PLANNER / SIGNATURE GUIDES
    K100973 EVOLUTION UNICONDYLAR KNEE SYSTEM
    K082567 STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION
    K081293 UNIVATION UNICONDYLAR KNEE SYSTEM
    K072704 UNICOMPARTMENTAL KNEE
    K071881 TRIATHLON PKR SYSTEM
    K070267 DEPUY GCK TIBIAL COMPONENTS
    K063515 TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE
    K061681 REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT
    K060412 ACTIVE UNICOMPARTMENTAL KNEE SYSTEM
    K053299 REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT
    K051721 GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM
    K050764 UNIGLIDE UNICONDYLAR KNEE PROSTHESIS
    K042093 VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS
    K040889 EXACTECH OPTETRAK UNICONDYLAR KNEE
    K040268 DEPUY PRESERVATION UNICONDYLAR TIBIA
    K033351 GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE
    K033810 NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEM
    K032052 UC-PLUS SOLUTION UNICONDYLAR KNEE
    K030446 REPICCI LOCKED KEEL TIBIAL BEARING
    K030193 ADVANCE LESS CONFORMING TIBIAL COMPONENT
    K022437 UNI KNEE
    K021621 FIXED BEARING UNI COMPONENT
    K020741 UNICONDYLAR KNEE
    K012800 SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM
    K014171 ADVANCE UNICONDYLAR KNEE SYSTEM
    K020264 REPICCI II UNICONDYLAR KNEE SYSTEM
    K012762 MJS POSTERIOR STABILIZED KNEE SYSTEM
    K012591 ADVANCE UNICONDYLAR KNEE SYSTEM
    K011138 OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT
    K011795 WORLAND UNICONDYLAR TIBIAL BEARING
    K011509 BARRETT UNICONDYLAR TIBIAL BEARING
    K010810 DEPUY PRESERVATION UNICONDYLAR KNEE PROSTHESIS
    K001451 MODIFICATION TO DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS
    K983657 OSTEONICS SERIES 7000 AD TIBIAL TRAY
    K000172 DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS
    K982859 UC-PLUS SOLUTION UNICONDYLAR KNEE SYSTEM
    K980665 REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTS
    K974434 OSTEONICS SERIES 7000 TOTAL KNEE ANTERIOR FEMORAL BLOCKS
    K971938 REPICCI II UNICONDYLAR KNEE
    K954481 P.F.C. UNI-COMPARTMENTAL KNEE SYSTEM
    K961900 TIBIAL TRAY PLUG, A PRODUCT LINE ADDITION TO THE AXIOM TOTAL KNEE SYSTEM
    K960617 ADVANCE TIBIAL COMPONENT
    K955778 NATURAL-KNEE II UNICOMPARTMENTALKNEE SYSTEM
    K944538 GAS PLASMA STERILIZATION
    K940389 S.T.E.P. UNI-KNEE
    K933935 CKS POROUS COATED FEMORAL COMPONENT
    K923011 OSTEONICS UNIX UNICOMPARTMENTAL
    K910968 P.F.C. UNICONDYLAR KNEE SYSTEM
    K911373 OSTEONICS ION IMPLANT MOD-ML UNIKNEE FEMORAL COMP
    K902538 WHITESIDE ORTHOLOC MODULAR TIBIAL AUGMENTATION
    K890044 BIOPRO ANATOMIC UNICOMPARTMENTAL KNEE
    K883969 UNI-KNEE COMPONENT OF THE NATURAL-KNEE SYSTEM
    K884837 KINEMAX TIBIAL WEDGE
    K882241 KIRSCHNER (R) UNICONDYLAR-II KNEE SYSTEM
    K873601 AGC UNICOMPARTMENTAL KNEE PROSTHESIS
    K864070 WHITESIDE ORTHOLOC (TM)
    K862125 ARIZONA CONDYLAR TIBIAL PLATEAU
    K860133 MODIFIED SYNATOMIC VARIABLE FIT TIBIAL PLATEAU
    K842367 HOWMEDICA KINEMATIC II TIBIAL WEDGE
    K834298 UNICONDYLAR FIBER METAL KNEE
    K831143 P.C.A. UNICOMPARTMENTAL KNEE PROSTHES
    K821341 IOI METAL BACKED TIBIAL COMPONENT
    K820002 BARD CONTOUR LINK S.K.I. KNEE SYS
    K820030 HOWMEDICA KINEMATIC TOTAL CONDYLAR KNEE
    K812012 TOWNLEY UNICONDYLAR KNEE
    K810540 KNEE PROSTHESIS
    K810060 P.C.A. TOTAL KNEE STEMMED TIBIA PROSTH
    K810616 MILLER MULTI-RADIUS TOTAL KNEE
    K810230 CONDYLAR KNEE W/METAL ENCAPSULATED TIB
    K802446 RANAWAT ESF TOTAL CONDYLAR KNEE
    K792619 RMC KNEE METAL SHOE TIBIAL COMPONENTS
    K792325 LIVERPOOL KNEE PROSTHESIS
    K790762 PLATFORM TCCK TOTAL KNEE
    K790350 POSTERIOR CRUCIATE CONDYLAR TIBIAL
    K790349 TOTAL CONDYLAR KNEE PROSTHESIS
    K790348 ANAMETRIC TIBIAL COMPONENT METAL TRAY
    K781608 CENTRAL PEG TIBIAL COMPONENT
    K780299 TOTAL KNEE SYSTEM
    K761278 TOTAL TIBIAL KNEE
    K760842 GEOMEDIC ANAMETRIC TOTAL KNEE
    K760744 TAVERNETTI-TENNANT
    K760334 PROSTEHSIS, TOTAL KNEE REPLACEMENT
    K760245 PROSTHESIS, RICHARDS MOD II KNEE

    FEI Numbers

    This FDA classification entry is associated with 127 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 127 registration numbers. Click on an entry to view related FDA registrations.