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510(k) Data Aggregation

    K Number
    K162764
    Device Name
    JAZZ FRAME SYSTEM
    Manufacturer
    IMPLANET S.A.
    Date Cleared
    2017-01-19

    (111 days)

    Product Code
    NKB
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K132303,K151740,K101682,K111940
    Why did this record match?
    Reference Devices :

    K132303, K151740, K101682, K111940

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

    The Jazz Claw System (hooks and rods) and the Jazz Frame System are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The Jazz Claw System (hooks and rods) and the Jazz Frame System are intended for posterior fixation for 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, spinal deformities (i.e., scoliosis and/or lordosis), tumor, pseudarthrosis or revision of a failed fusion attempt.

    The Jazz Claw System (hooks and rods) and the Jazz Frame System are indicated as an adjunct to fusion to treat adolescent idiopathic scolosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

    Device Description

    The JAZZ Frame spinal implants are spinal fixation devices consisting of the following components: T-bars, straight rods, connectors, and surgical instruments. The T-bars are fixed closed transverse connectors. The rods have been previously cleared as part of the ISS system and are used with the JAZZ Frame. The JAZZ Connector and JAZZ Braid have been previously cleared and are also used with the JAZZ Frame. There is no change to the previously cleared JAZZ instruments.

    Once the fusion rods have been bent to the desired shape, a T-bar is positioned at the top and middle of the two bars, and then tightened in place using the screwdriver. The caudal parts of the rods are inserted into heads of pedicle screws that have been previously implanted. The cranial end of the construct is then secured with JAZZ Connectors, and the screws of the T-bars undergo final tightening.

    AI/ML Overview

    The provided text describes the 510(k) premarket notification for the JAZZ Frame System, a spinal fixation device. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance metrics in a clinical or analytical setting against such criteria.

    The "Performance Data" section briefly mentions:

    • Static axial, rotational, and bending testing per ASTM F1798.
    • Bacterial endotoxin testing (BET) as specified in ANSI/AAMI:ST72:2011 to achieve an Endotoxin limit of
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