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510(k) Data Aggregation

    K Number
    K090605
    Device Name
    CLAMPFIX
    Manufacturer
    SYNTHES (USA)
    Date Cleared
    2009-11-06

    (245 days)

    Product Code
    NKB,KWP,KWQ,MNH,MNI
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K010658,K963045,K992739,K082914,K022949
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Synthes USS (including USS Side-Opening, USS Dual-Opening, USS Small Stature (which includes small stature and pediatric patients), USS VAS variable axis components, USS Fracture, Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, and ClampFix) are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/illium), a posterior hook fixation system (T1-L5), or as an anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, Schevermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis).

    When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.

    When used with the 3.5/6.0-mm parallel connectors, the Synthes USS (including USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, and ClampFix) can be linked to the CerviFix System. In addition, when used with 3.5/5.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the Cervifix System. When used with the 5.0/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS (including USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea Monoaxial, USS Polyaxial, USS fliosacral, and ClampFix).

    In addition, Synthes USS (including USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, and ClampFix) can be interchanged with all USS 6.0 mm rods and transconnectors.

    Device Description

    The Synthes ClampFix System is an addition to Synthes' existing posterior thoracolumbar spine systems. The ClampFix implants consist of a family of clamps designed to facilitate construct assembly and complex spine manipulation. The new implants for the system are manufactured from Titanium Aluminum Niobium (Ti-6Al-7Nb) ASTM F1295, the same as the predicates.

    AI/ML Overview
    1. Acceptance Criteria and Reported Device Performance:
    Acceptance CriteriaReported Device Performance
    Substantial equivalence to predicate devices in design, function, material, and intended use.Bench testing results demonstrate that the Synthes ClampFix System is substantially equivalent to the predicate devices.

    1. Sample Size Used for Test Set and Data Provenance:

      • Not applicable. The document states "Clinical data and conclusions were not needed for this device." The evaluation was based on non-clinical bench testing.

    2. Number of Experts and Qualifications for Ground Truth:

      • Not applicable, as no clinical data or expert-established ground truth was required.

    3. Adjudication Method for Test Set:

      • Not applicable, as no clinical data or expert consensus was involved.

    4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

      • No, an MRMC comparative effectiveness study was not done. The document explicitly states "Clinical data and conclusions were not needed for this device."

    5. Standalone Performance Study:

      • Yes, a standalone performance was done through "Bench testing", which focused on the device itself without human-in-the-loop performance evaluation.

    6. Type of Ground Truth Used:

      • The ground truth for proving substantial equivalence was based on bench testing results, comparing the device's design, function, and material to predicate devices.

    7. Sample Size for Training Set:

      • Not applicable. This document describes a 510(k) submission for a medical device (spinal fixation system), not a software or AI-based device that would typically involve a "training set" in the machine learning context.

    8. How Ground Truth for Training Set Was Established:

      • Not applicable, as there was no training set in the context of this device. The evaluation was based on comparisons to predicate devices through bench testing.
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