LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K163011
    Device Name
    PHA S1 Spinal System
    Manufacturer
    Phamedica, Inc.
    Date Cleared
    2017-06-29

    (244 days)

    Product Code
    NKB
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K000236,K111940
    Why did this record match?
    Applicant Name (Manufacturer) :

    Phamedica, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Phamedica PHA S1 Spinal System is intended for posterior non-cervical pedicle fixation of Thoracic, Lumbar, Sacral/ Iliac Spine in skeletally mature patients, as an adjunct to fusion using autogeneous bone graft or all of the following indications:

    · Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)

    • · Spondylolisthesis
    • · Trauma (i.e., fracture or dislocation)
    • · Spinal Stenosis
    • · Curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
    • Tumor
    • Pseudoarthrosis
    • · Failed previous fusion in skeletally mature patients.
    Device Description

    Phamedica PHA S1 Spinal Fixation system consists of Poly Axial screws, Mono Axial Screws, Poly Axial and Mono Axial Reduction Screws, Rods, Set Screws, Transverse and Offset connectors made from Titanium Alloy Ti6AL4V which can be variously assembled for stabilization and to promote bone fusion during the normal healing process following surgical correction of disorders of the spine.

    AI/ML Overview

    This document is a 510(k) premarket notification for a spinal fixation system, not an AI/ML medical device. Therefore, the information requested about acceptance criteria, study design, ground truth establishment, and expert involvement for an AI medical device cannot be found within this document.

    The document focuses on:

    • Device Description: PHA S1 Spinal System, composed of screws, rods, and connectors made from Titanium Alloy Ti6AL4V.
    • Indications for Use: Posterior non-cervical pedicle fixation for various spinal conditions (degenerative disc disease, spondylolisthesis, trauma, stenosis, curvatures, tumor, pseudoarthrosis, failed previous fusion).
    • Performance Data: Non-clinical mechanical testing (Static compression bending, Static torsion, Dynamic compression bending) per ASTM F1717-15.
    • Conclusion: The device is substantially equivalent to predicate devices based on overall technology characteristics and mechanical performance data.

    There is no mention of an algorithm or AI component in this device. Therefore, it's not possible to provide the requested details regarding AI device performance.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1