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510(k) Data Aggregation

    K Number
    K071876
    Device Name
    CROSS.BONE
    Manufacturer
    TRIMED, INC.
    Date Cleared
    2007-12-17

    (164 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K032268,K051774,K060061
    Why did this record match?
    Device Name :

    CROSS.BONE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Cross.Bone Blocks - CROSS.BONE BLOCK is recommended for bone reconstructive surgery or as a bone filler following loss of uninfected bone substance of artificial or degenerative origin, suitably reduced, fixed and stabilized where necessary.
    — Filling losses of bone material resulting from a fracture.
    — Filling losses of bone material after the resection of benign tumors or cysts

    Cross.Bone Bottles - CROSS.BONE BOTTLE is recommended for bone reconstructive surgery or as a bone filler following loss of uninfected bone substance of artificial or degenerative origin, suitably reduced, fixed and stabilized where necessary.

    • Filling losses of bone material resulting from a fracture.
      – Filling losses of bone material after the resection of benign tumors or cysts.

    Cross.Bone Syringe - CROSS.BONE SYRINGE is recommended for bone reconstructive surgery or as a bone filler following loss of uninfected bone substance of artificial or degenerative origin, suitably reduced, fixed and stabilized where necessary.

    • Bone filler following a fracture,
    • Bone filler following resection of benign tumors or cysts,
      When the cavity to be filled is large, it is recommended to cover it with a resorbable membrane.

    Cross.Bone Wedge - CROSS.BONE WEDGE is recommended for tibial osteotomy with internal fixation, and necessarily in combination with an osteosynthesis procedure (metallic plates and screws).

    Device Description

    Cross.Bone is a resorbable, biphasic ceramic implant composed of 60% hydroxyapatite and 40% ß-tricalcium phosphate in the form of granules. It is used as a bone filler and for bone reconstruction.

    AI/ML Overview

    This document is a 510(k) summary for a medical device called "Cross.Bone," a resorbable, biphasic ceramic implant used as a bone filler. It does not describe an AI/ML powered medical device. Therefore, it does not contain the information required to answer your prompt, such as acceptance criteria, study details, sample sizes, expert involvement, or grand truth methods related to AI/ML performance.

    The document discusses the device's indications for use, description, and substantial equivalence to legally marketed predicate devices, which is a regulatory pathway for medical devices in the US that do not require an AI/ML component.

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