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510(k) Data Aggregation

    K Number
    K252997

    Validate with FDA (Live)

    Device Name
    HyperFlex® Bunion Correction System
    Manufacturer
    Hyperflex Medical
    Date Cleared
    2025-12-11

    (84 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    13 - 120
    Reference & Predicate Devices
    K090107,K241995
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The HyperFlex® Medical HyperFlex® Bunion Correction System is intended for use in reconstruction (correction) of the hallux valgus deformity by holding the reduction of the 1st metatarsal-2nd metatarsal intermetatarsal (IM) angle in adults and pediatric patients aged ≥13 years in which growth plates have fused.

    Device Description

    The HyperFlex® Medical HyperFlex Bunion System is an implantable device and accompanying instrumentation used to treat a hallux valgus deformity (bunion). It includes an implant with components that attach to the 1st and 2nd metatarsals which are joined by a flexible central section. The system holds the IM angle between the 1st and 2nd metatarsal without restricting range of motion. The implant will be offered in several sizes to fit the anatomical needs of the patient population.

    AI/ML Overview

    N/A

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