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510(k) Data Aggregation

    K Number
    K212991
    Device Name
    Osteorevive
    Manufacturer
    Bone Solutions, Inc.
    Date Cleared
    2022-01-21

    (123 days)

    Product Code
    MQV,OIS
    Regulation Number
    888.3045
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K173362,K071004,K140375
    Why did this record match?
    Reference Devices :

    K173362

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

    OSTEOREVIVE™ is intended for bony voids or defects of the extremities, posterolateral spine, and pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects created by traumatic injury to the bone. OSTEOREVIVE™ can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure only in the extremities and pelvis. Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process. OSTEOREVIVE™ is intended to be placed into bony voids either before or after final fixation. OSTEOREVIVE™ is resorbed and replaced with bone during the healing process. OSTEOREVIVE™ must be used with morselized autograft bone at a ratio of 1:1 by volume in the posterolateral spine. OSTEOREVIVE™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

    Device Description

    OSTEOREVIVE™ is a magnesium-based synthetic bone void filler that is drillable, resorbable, radiopaque, and osteoconductive. OSTEOREVIVE™ consists of a powder component and a liquid component (modified saline solution) that are mixed at the time of surgery. The powder components include ß-tricalcium phosphate, magnesium oxide, monopotassium phosphate, and monosodium phosphate. The mixing liquid is saline with monosodium phosphate. After mixing and setting OSTEOREVIVE™ is a non-porous solid material. OSTEOREVIVE™ is provided sterile to the end user in 5 cc, 10 cc, and 15 cc sizes.

    AI/ML Overview

    The provided text is a 510(k) summary for the OSTEOREVIVE™ bone void filler and does not contain information about an AI/ML-driven medical device requiring the specified acceptance criteria and study details.

    The document describes a resorbable calcium salt bone void filler device and its substantial equivalence to predicate devices, referencing performance testing related to chemical composition, physical properties, sterilization, shelf life, biocompatibility, bacterial endotoxin testing, drillability, and animal testing in a rabbit posterolateral spine fusion model. There is no mention of an AI/ML component, human readers, or any typical acceptance criteria associated with AI/ML device performance (e.g., sensitivity, specificity, AUC).

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets those criteria, as the provided text does not relate to an AI/ML device.

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