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510(k) Data Aggregation

    K Number
    K081060
    Device Name
    FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5
    Manufacturer
    CORE ESSENCE ORTHOPAEDICS, LLC
    Date Cleared
    2008-12-24

    (254 days)

    Product Code
    GAQ
    Regulation Number
    878.4495
    Why did this record match?
    Applicant Name (Manufacturer) :

    CORE ESSENCE ORTHOPAEDICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ferroFibre 14 Stainless Steel Sutures are intended for use in soft tissue approximation and for use in abdominal wound closure, hernia repair, sternal closure and certain orthopaedic procedures including cerclage and tendon repair.
    Device Description
    The ferroFibre™ Stainless Steel Suture is available in United States Pharmacopocia (USP) sizes 5-0 to #5 in various lengths. The ferroFibre multifilament stainless stecl sutures are supplied storile, armed with cutting needles. The sutures are fabricated from 316 stainless steel that meets ASTM F138-03.
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    K Number
    K071477
    Device Name
    REVERTO 55 AND 37 SHAPE MEMORY STAPLES
    Manufacturer
    CORE ESSENCE ORTHOPAEDICS, LLC
    Date Cleared
    2007-08-15

    (78 days)

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

    CORE ESSENCE ORTHOPAEDICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    reVERTO™ Shape Memory Staples are intended for use in: Fixation of Osteotomies of the Hand, Foot and Tibia Arthrodesis of the Joints of the Hand and Foot Fixation of Soft Tissue to Bone, as in the case of the Anterior Cruciate Ligament reVERTO™ Shape Memory Staples are also indicated for adjunctive fixation of Small Bone Fragments of: The Upper Extremity, such as the Radius, Ulna, Humerus, Clavicle and Scapula The Lower Extremity, such as the Tibia, Fibula and the Femur The Upper Torso, such as the Sternum and the Ribs
    Device Description
    reVERTO™ Shape Memory Staples are dynamic compression implants that use shape memory metal nickel-titanium alloy called NiTinol (see below for more information on NiTinol). The NiTinol construction causes the legs of the implant to deflect, thereby creating a compressive force across the site of fixation. reVERTO Shape Memory Staples are advantageous to screws and plates in that they require less disruption of the surrounding bone for implantation and provide a 'low-profile' fixation. The most important factor related to the use of NiTinol is its ability to maintain a compressive force across the site of fixation during the healing process.
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    K Number
    K071520
    Device Name
    RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X
    Manufacturer
    CORE ESSENCE ORTHOPAEDICS, LLC
    Date Cleared
    2007-08-10

    (67 days)

    Product Code
    MBI, HWC, JDR
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    CORE ESSENCE ORTHOPAEDICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    reNOVO Suture Anchors are intended to secure soft tissue to bone of: The Shoulder: Bankart Repair SLAP Lesion Repair Acromio-Clavicular Separation Roatator Cuff Repair Capsule Repair Biceps Tenodesis Deltoid Repair The Elbow: Ulnar or Radial Collateral Ligament Reconstruction Bicep Tendon Reconstruction Tennis Elbow Repair The Hand and Wrist: Scapholunate Ligament Reconstruction Ulnar / Radial Collateral Ligament Reconstruction Collateral Ligaments around the PIP, DIP and MCP Joints Flexor and Extensor Tendons The Ankle and Foot: Lateral Stabilization Medial Stabilization Achilles Tendon Repair / Reconstruction Hallux Valgus Reconstruction Mid and Rear Foot Reconstruction
    Device Description
    The reNOVO™ Suture Anchors range in size from 2.0mm to 5.5mm in diameter. The anchor portion consists of a threaded titanium (ASTM F136/ ISO 5832-3) segment that provides a self drilling and self tapping thread. The anchor eyelet provides a means to attach the range of suture sizes utilized on the anchors. The size of sutures used in the reNOVO line range from size 3-0 thru size 2 (USP) nonabsorbable UHMW polyethylene UltraFibre™ sutures. A single use driver and handpiece hold the excess suture and deliver the preloaded anchor into the bone. The suture strands are used to reapproximate and secure the soft tissue to the bone. The reNOVO™ Suture Anchor will be provided sterile for single use applications. The sizes and materials are designed to address the indications cited.
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