LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K083743

    Validate with FDA (Live)

    Device Name
    CAPSURE PS SYSTEM
    Manufacturer
    SPINE WAVE, INC.
    Date Cleared
    2009-01-13

    (28 days)

    Product Code
    MNI,MNH
    Regulation Number
    888.3070
    Type
    Special
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K083353,K052847,K070300
    Predicate For
    K100122,K111913,K120646
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the CapSure® PS System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

    The CapSure® PS System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S1), and for whom the device is intended to be removed after solid fusion is attained.

    Device Description

    The CapSure® PS System consists of a selection of non-sterile, single use titanium alloy rod and screw components that are assembled to create a rigid spinal construct. The rod and screw components of the CapSure® PS System are attached to the non-cervical spine in order to stabilize the spine during fusion of the vertebral bodies, and are intended to be removed after spinal fusion is achieved.

    This purpose of this submission is to gain clearance for the addition of an optional Cross Connector component to the CapSure® PS System. The Cross Connector is a non-sterile, single use, titanium allow device which can be used with the CapSure® PS System for added stability. The Cross Connector is available in lengths ranging from 35mm to 100mm.

    AI/ML Overview

    The provided documentation does not contain information regarding the acceptance criteria, device performance tables, sample sizes for test and training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

    The document is a 510(k) summary for the CapSure® PS System, a pedicle screw spinal system, and its optional Cross Connector component. It primarily focuses on demonstrating substantial equivalence to predicate devices through mechanical testing, rather than reporting on the performance of an AI/ML-based device against specific acceptance criteria.

    Therefore, I cannot fulfill your request with the information provided.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1