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510(k) Data Aggregation

    K Number
    K143731
    Device Name
    IMPLANET Spine System (ISS)
    Manufacturer
    IMPLANET S.A.
    Date Cleared
    2015-04-14

    (106 days)

    Product Code
    NKB,KWP,MNH,MNI,OSH
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K120564,K132303
    Why did this record match?
    Device Name :

    IMPLANET Spine System (ISS)

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

    The IMPLANET Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The IMPLANET Spine System is intended for posterior, non-cervical pedicle and non-pedicle 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 deformities (i.e., scoliosis, kyphosis and/or lordlosis), tumor, pseudarthrosis, or revision of a failed fusion attempt. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the IMPLANET Spine System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

    Device Description

    The IMPLANET Spine System is a posterior instrumentation system. The polvaxial screws are made of Ti6Al4V titanium alloy compliant with ISO 5832-3. The polyaxial screw is comprised of three sections: the pedicle screw; the head; and a ring that connects the screw to the head. The polyaxial screws are offered in diameters ranging from 5.0 to 7.5 mm and in lengths ranging from 35 to 60 mm.

    The monoaxial pedicle screws are made of Ti6Al4V titanium alloy compliant with ISO 5832-3 and are available in 5.0 mm. 7.0 mm. and 8.0 mm diameters. The screws range in length from 35 to 60 mm.

    The system includes both straight and pre-bent rods made of Ti6AI4V titanium alloy.

    The transverse connectors are composed of Ti6AI4V titanium alloy compliant with ISO 5832-3. These connectors are used to build a transverse connection between two union rods.

    The hooks are made of Ti6Al4V titanium alloy and are provided in multiple configurations.

    The purpose of this 510(k) is to extend the ISS line to include:

    • New monoaxial and polyaxial screws .
    • Cobalt Chromium rods
    • New Ti6Al4V titanium alloy rods ●
    • Offset connector and associated offset connector screws
    • Rod to rod connectors
    • . New instruments

    The IMPLANET Spine System has principles of operation substantially similar to other pedicle screw-based systems for the indications listed.

    The IMPLANET Spine System components may be used for posterior pedicle screw fixation in pediatric cases: polyaxial and monoaxial screws, rods, transverse connectors and rods. The purpose of the subject 510(k) notice is for a line extension to incorporate additional device dimensions and Cobalt Chromium rods, as well as compatible additional instruments, to the company's cleared system.

    AI/ML Overview

    The provided document is a 510(k) summary for the IMPLANET Spine System, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory purposes, rather than presenting a clinical study or performance study with defined acceptance criteria for an AI/algorithm-driven device.

    Therefore, the information requested in your prompt (e.g., acceptance criteria, test set sample size, ground truth establishment, MRMC study, training set size) is not applicable to this type of regulatory submission and is not present in the provided text.

    The document describes a mechanical performance study and biocompatibility testing for the physical spinal implant system. It confirms that:

    • Acceptance Criteria for Performance Data: The goal was to confirm that modifications "do not adversely impact mechanical strength compared to the predicate" and that the device is "biocompatible." Specific numerical acceptance criteria are not provided in this summary, but the general criteria are comparative to the predicate.
    • Reported Device Performance:
      • Static axial gripping capacity, static flexion/extension bending, static axial torque gripping capacity (ASTM F1798)
      • Static compression bending (ASTM F1717)
      • Static torsion (ASTM F1717)
      • Dynamic compression bending (ASTM F1717)
      • Cytotoxicity (ISO 10993-5)
      • Acute systemic toxicity (ISO 10993-11)
      • Results: "All results confirmed that the modifications to the device described in this submission do not adversely impact mechanical strength compared to the predicate. In addition, the device is biocompatible."

    The other requested information (sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, type of ground truth for AI) is specific to the evaluation of AI/algorithmic devices and is not relevant to this 510(k) submission for a physical implant system.

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