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510(k) Data Aggregation

    K Number
    K110662
    Device Name
    ADAPTIVE WEDGE
    Manufacturer
    ADAPTIVE SPECIALTY, LLC
    Date Cleared
    2012-03-12

    (370 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADAPTIVE SPECIALTY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Adaptive Wedge is intended to be used for internal bone fixation for small bone fractures or osteotomies in the ankle and foot such as: - Opening wedge osteotomies of Hallux Valgus - Evans lengthening osteotomies . - · Cotton osteotomy This device is intended for use with ancillary fixation and is not intended for use in the spine.
    Device Description
    The Adaptive Wedge has a distinct design to help facilitate bony integration once implanted. It has angular teeth to prevent backing out. It is offered in varying widths and thicknesses to accommodate a variety of small bone applications. Materials: PEEK Optima LT1 per ASTM F2026. Titanium alloy per ASTM F136. Function: Used for angular correction of gaps and bony voids of small bones in the ankle and foot.
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    K Number
    K083425
    Device Name
    FUSION ADVANTAGE CERVICAL CAGE, FUSION ADVANTAGE LUMBAR CAGE
    Manufacturer
    ADAPTIVE SPECIALTY, LLC
    Date Cleared
    2009-03-20

    (121 days)

    Product Code
    ODP, MAX
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADAPTIVE SPECIALTY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fusion Advantage Cervical Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radioular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Fusion Advantage Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone. Fusion Advantage Cervical Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. The Fusion Advantage Lumbar Cage 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). Fusion Advantage Lumbar Cage implants are to be used with autogenous bone graft and implanted via an open posterior, transforaminal or an lateral approach. The Fusion Advantage Lumbar Cages are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous nonfusion spinal surgery at involved level may be treated with the device.
    Device Description
    The Adaptive Specialty Fusion Advantage cervical cage was developed as an intercorporal implant for anterior cervical spondylodesis. The Fusion Advantage System was especially adapted to the local anatomy in order to secure the surgical result as well as possible. Its inferior and superior sides are flat with ridges on both surfaces to prevent migration. The implant is oval shaped with a large central graft space to help facilitate bony integration once implanted. In the lateral view, the implant has a 2.5° lordotic form. The Adaptive Specialty Fusion Advantage Lumbar cage was developed as an implant for the posterior stabilization of the lumbar spinal column. The Adaptive Specialty Fusion Advantage implant has ridges on both its inferior and superior surfaces to prevent migration. It is a rectangular shape with a large rectangular graft space and lateral holes help facilitate bony integration once implanted. Materials: PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications) Function: To maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion.
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