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510(k) Data Aggregation

    K Number
    K220717
    Device Name
    RedPoint Medical's Better Bunion System
    Manufacturer
    Redpoint Medical, LLC
    Date Cleared
    2022-06-09

    (90 days)

    Product Code
    PBF
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    Redpoint Medical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Better Bunion System is intended to be used as a surgical instrument to assist in pre-operative planning and/or in guiding the marking of bone and/or guide surgical instruments in non-acute, non-joint replacing osteotomies in the foot and ankle for adult and pediatric patients 12 years of age and older. Better Bunion cutting guides are intended for single use only.
    Device Description
    The RedPoint Medical Better Bunion system includes single use, patient specific bone resection guides designed from DICOM files from a patients' CT scans and a surgeon's prescription. The Better Bunion system includes single use and reusable instruments to facilitate surgery. The Better Bunion patient specific bone resection guides assist the surgeon in cutting bone in the foot and ankle according to the pre-surgical plan. The quides are individually manufactured for each patient using a validated design and manufacturing process with strict procedures for transfer and conversion of patient images from DICOM files to digital models (STL files), and in turn to patient specific bone resection guides that are additively manufactured with titanium alloy conforming to ASTM F3001. The bone cutting guides are single use devices and provided clean, not sterile to the end user.
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