BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇹 Austria

    I.T.S. PRS Phoenix II

    K Number: K260054 · Decision Apr 24, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    8
    Review Days
    106

    Basic Information

    Device Name
    I.T.S. PRS Phoenix II
    K Number
    K260054
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    I.T.S. GmbH
    Date Received
    January 8, 2026
    Decision Date
    April 24, 2026
    Product Code
    HRS
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HRS Plate, Fixation, Bone

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    Other Clearances by I.T.S. GmbH

    K Number Device Name
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    K233134 I.T.S. INS Proximal Femur Nail
    K210935 I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)
    K142418 I.T.S. Hand Locking Plates System - HLS
    K132945 CFN-CANNULATED FEMUR NAIL, CTN-CANNULATED TIBIA NAIL, CHN-CANNULATED HUMERAL NAIL
    K131722 I.T.S. EXTREMITY FIXATION SYSTEMS
    K130008 DISTAL ULNA LOCKING PLATE (DUL), ULNA OSTEOTOMY LOCKING PLATE (UOL), 3.0 CANCELLOUS LOCKING SCREW, 3.0 CORTICAL LOCKING