LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K242302
    Device Name
    RejuvaKnee™ Collagen Meniscus Implant
    Manufacturer
    Collagen Matrix, Inc.
    Date Cleared
    2024-10-02

    (58 days)

    Product Code
    OLC
    Regulation Number
    878.3300
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K170364
    Why did this record match?
    Device Name :

    RejuvaKnee™ Collagen Meniscus Implant

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

    RejuvaKnee is intended for use in surgical procedures for the reinforcement and repair of the medial meniscus. In repairing and reinforcing medial meniscal defects, the patient must have an intact meniscal rim and anterior and posterior horns for attachment of the mesh. In addition, the surgically prepared site for the RejuvaKnee must extend at least into the red/white zone of the meniscus to provide sufficient vascularization.

    RejuvaKnee reinforces soft tissue and provides a reasonable scaffold that is replaced by the patient's own soft tissue. The RejuvaKnee is not a prosthetic device and is not intended to replace normal body structure.

    Device Description

    The RejuvaKnee™ Collagen Meniscus Implant is comprised primarily of bovine Type I collagen (nominally 99%) derived from meniscus. The device is provided in a semi-lunar shape with a triangular cross section to be used to reinforce weakened soft tissue and provide a resorbable scaffold that is replaced by the patient's own tissue.

    RejuvaKnee is supplied sterile and is intended for single use.

    AI/ML Overview

    This is a 510(k) summary for the RejuvaKnee™ Collagen Meniscus Implant.
    The device is a resorbable scaffold made of bovine Type I collagen intended for the reinforcement and repair of medial meniscal defects. It is compared to the Ivy Sports Medicine Collagen Meniscus Implant (K170364) as a predicate device.

    Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document provides a comparison of features between the RejuvaKnee™ Collagen Meniscus Implant and its predicate. Acceptance criteria are implied by the reported values and the claim of substantial equivalence to the predicate.

    FeatureAcceptance Criteria (Implied by Predicate & Device Performance)RejuvaKnee™ Collagen Meniscus Implant Performance
    Indications for UseSubstantially equivalent to predicateSame as predicate
    Material CompositionType I bovine collagenPrimarily Type I bovine collagen
    Material OriginBovineBovine
    Tissue SourceNot explicitly defined as an acceptance criterion; comparison shownMeniscus
    Physical FormSemi-lunar shape with triangular cross-sectionSemi-lunar shape with a triangular cross-section
    Product Sizes (cm)Comparable to predicateSmall Medial - 7.5 mm; Large Medial - 9 mm
    Porosity - SEMSufficient to allow for cellular integration from host tissue (>5 micron for RejuvaKnee)Provides sufficient porosity to allow for cellular integration from host tissue (>5 micron)
    pHComparable to predicate (predicate: 7.12)6 - 9.5
    Tensile Strength (kg/cm²)Comparable to predicate (predicate: 62.5 kg/cm²)≥ 150
    Suturability (kg)Comparable to predicate (predicate: 0.86 ±0.08 kg)≥ 0.5
    Thermal Stability (°C)Comparable to predicate (predicate: 61±1 °C)60 ± 3
    BiocompatibilityMeets ISO 10993 series of testingMeets ISO 10993 biocompatibility series of testing
    SterilitySterile, SAL 10-6 using Gamma irradiationSterile, SAL 10-6 using Gamma irradiation
    PyrogenicityNon-pyrogenic -
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1