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    K Number
    K152355
    Device Name
    Twin Peaks Lumbar Interbody Fusion System
    Manufacturer
    SPINEWAY
    Date Cleared
    2015-12-10

    (112 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K081917,K101720,K080588,K133216,K082014
    Why did this record match?
    Device Name :

    Twin Peaks Lumbar Interbody Fusion System

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

    The Twin Peaks Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Twin Peaks System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The Twin Peaks System must be used with supplemental fixation cleared by FDA for use in the lumbar spine.

    Device Description

    The Twin Peaks Lumbar Interbody Fusion System consist of 3 designs, PLIF & PLIF BS, TLIF and OLIF. The PLIF and TLIF implants are available as a lordotic form, while the OLIF implants are provided with no lordosis. The implants are available in various heights and lengths to accommodate patients' anatomy. The implants are provided sterile, and a set of instrument for implantation is provided to facilitate implantation. Two radiographic markers made of tantalum per ASTM F560 are included in the PLIF and OLIF PEEK implants, and three radiographic markers made of tantalum per ASTM F560 are included in the TLIF PEEK implant to allow radiographic visualization.

    AI/ML Overview

    This document is a 510(k) premarket notification for the Twin Peaks Lumbar Interbody Fusion System. It describes the device, its indications for use, and the performance testing conducted to demonstrate substantial equivalence to predicate devices. However, the document does not contain information about an AI/ML device or its acceptance criteria and a study to prove it meets them. This notification is for a traditional medical device (intervertebral body fusion system) and the performance testing refers to mechanical and material tests, not AI/ML algorithm performance.

    Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML device based on the provided text.

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