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510(k) Data Aggregation

    K Number
    K233592
    Device Name
    BioPoly Radial Head Implant
    Manufacturer
    BioPoly, LLC
    Date Cleared
    2024-03-13

    (126 days)

    Product Code
    KWI
    Regulation Number
    888.3170
    Why did this record match?
    Applicant Name (Manufacturer) :

    BioPoly, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BioPoly Radial Head Implant is indicated for: - · Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain. crepitation, and decreased motion at the radio-humeral and or proximal radio-ulnar joint with: - o joint destruction and/or subluxation visible on x-ray; and/or - o resistance to conservative treatment - · Primary replacement after fracture of the radial head - · Symptomatic sequelae after radial head resection - · Revision following failed radial head arthroplasty
    Device Description
    The BioPoly Radial Head Implant is a hemiarthroplasty device designed to restore the articular surface and spacing of the proximal head of the radius in patients following fracture resection and/or degenerative disability The implant is supplied with head diameters of 20mm, 23mm, and 26mm; and stem diameters of 6mm, 7mm, 8mm, +3mm, and +6mm height offsets for the radius in patients following fracture, resection, and/or degenerative disability.
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    K Number
    K222964
    Device Name
    BioPoly Lesser Toe Hemiarthroplasty Implant
    Manufacturer
    BioPoly, LLC
    Date Cleared
    2022-11-22

    (56 days)

    Product Code
    KWD
    Regulation Number
    888.3730
    Why did this record match?
    Applicant Name (Manufacturer) :

    BioPoly, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BioPoly Lesser Toe Hemiarthroplasty implant is intended to replace the distal metatarsal surface in patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions: hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement.
    Device Description
    The BioPoly Lesser Toe Hemiarthroplasty Implant is a hemiarthroplasty device specifically designed to restore the articular surface of the lesser metatarsal bones in patients with degenerative and post-traumatic arthritis. The implant is comprised of BioPoly (UHMWPE/hyaluronic acid) direct compression molded onto a Ti-6A1-4V stem. A porous stem option is available, which additionally contains OsteoSync™ Ti, a porous titanium (CP Ti) material.
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    K Number
    K203634
    Device Name
    BioPoly Great Toe Hemiarthroplasty Implant
    Manufacturer
    BioPoly, LLC
    Date Cleared
    2021-02-02

    (53 days)

    Product Code
    KWD
    Regulation Number
    888.3730
    Why did this record match?
    Applicant Name (Manufacturer) :

    BioPoly, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BioPoly Great Toe Hemiarthroplasty implant is intended to replace the distal metatarsal surface of the great toe of patients with degenerative and post-traumatic arthritis in the presence of good bone stock along with the following clinical conditions: hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement.
    Device Description
    The BioPoly Great Toe Hemiarthroplasty Implant is a hemi-arthroplasty device specifically designed to restore the articular surface of the first metatarsal bone in patients with degenerative and post-traumatic arthritis. The implant is comprised of BioPoly (UHMWPE/hyaluronic acid) direct compression molded onto a Ti-6Al-4V stem. A porous stem option is available, which additionally contains OsteoSync™ Ti, a porous titanium (CP Ti) material.
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