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510(k) Data Aggregation

    K Number
    K251555
    Manufacturer
    Date Cleared
    2025-11-06

    (169 days)

    Product Code
    Regulation Number
    888.3040
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Pace Surgical Ultra™ Compression Screw System is intended for the internal fixation and stabilization of arthrodeses, osteotomies, fractures, and nonunions of the foot and ankle. The System is specifically indicated for:

    Fractures and Osteotomies

    • Fractures of the tarsals, metatarsals and other fractures of the foot (i.e. LisFranc)
    • Avulsion fractures and fractures of the 5th metatarsal (i.e. Jones Fracture)
    • Talar fractures
    • Ankle fractures
    • Navicular fractures
    • Fractures of the fibula, malleolus, and calcaneus
    • Metatarsal and phalangeal osteotomies
    • Weil osteotomy
    • Calcaneal osteotomy

    Fusion resulting from neuropathic osteoarthopathy (Charcot), example:

    • Medial and lateral column
    • Subtalar, talonavicular, and calcaneocuboid

    Arthrodesis and Deformity Correction

    • 1st MTP arthrodesis
    • Metatarsal deformity correction
    • Tarsometatarsal joint arthrodesis
    • Naviculocuneiform joint arthrodesis
    • Talonavicular arthrodesis
    • Subtalar joint arthrodesis
    • Triple arthrodesis
    • Medial column arthrodesis
    • Subtalar joint distraction arthrodesis
    • Ankle arthrodesis
    • Lateralizing calcaneal osteotomy
    • Lateral column lengthening
    • Hammertoe

    Hallux Valgus Correction

    • Fixation of osteotomies (i.e. Akin, Scarf, Chevron)
    • Interphalangeal (IP) arthrodesis
    • Proximal, midshaft, or distal osteotomy
    • Lapidus arthrodesis
    Device Description

    The Ultra Compression Screw System is intended for the internal fixation and stabilization of arthrodeses, osteotomies, fractures, and nonunions of the foot and ankle. The system consists of various solid and cannulated screws in diameters ranging from 2-8mm with partial and fully threaded variants. Screws are available in headed and headless variants. Compatible washers are also included in the system. All screws and washers are manufactured from titanium alloy per ASTM F136.

    AI/ML Overview

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