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510(k) Data Aggregation

    K Number
    K252254
    Device Name
    Osteotomy Wedge System
    Manufacturer
    SiNAPTIC Surgical
    Date Cleared
    2025-10-17

    (88 days)

    Product Code
    PLF
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K220513,K243231,K240461,K201314
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SiNAPTIC Osteotomy Wedge System is intended to be used for internal bone fixation for fractures or osteotomies in the ankle and foot, such as:

    1. Opening wedge osteotomies of the bones of the foot, including osteotomies for Hallux Valgus
    2. Opening wedge of the medial cuneiform or Cotton osteotomies.
    3. Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z-Osteotomy)
    4. Metatarsal Cuneiform osteotomies
    5. Nonunion of arthrodesis of the Midfoot including Metatarsal Cuneiform osteotomies (TMT or Lapidus)
    6. Hindfoot osteotomies such as Ankle fusion and Subtalar fusion

    The Osteotomy Wedge System MTP Wedges are intended to be used for internal fixation of metatarsal bones that have been surgically prepared (osteotomy) for correction of deformity.

    The Osteotomy Wedge System is indicated for use with supplemental fixation.

    The Osteotomy Wedge System is not indicated for use in the spine.

    Device Description

    The Osteotomy Wedge System devices are a sterile, single use Silicon Nitride (Si₃N₄) implants. The wedges are designed in a variety of shapes, each available in multiple footprints and thickness. The Osteotomy Wedge System is intended to be used for internal bone fixation for opening or lengthening osteotomies in the foot and ankle. The wedges contain an insertion feature as well as a central, open area for packing graft material or insertion of supplemental fixation.

    AI/ML Overview

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