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510(k) Data Aggregation

    K Number
    K140970
    Device Name
    ONE-PIECE PEEK FUSION IMPLANT
    Manufacturer
    MTP SOLUTIONS LLC
    Date Cleared
    2014-05-13

    (27 days)

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

    MTP SOLUTIONS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The One-Piece PEEK Fusion Implant is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.
    Device Description
    The One-Piece PEEK Fusion Implant is manufactured from polyetheretherketone (PEEK). It is threaded on one end and ridged on the other to engage either side of an osteotomy or reconstruction site. The One-Piece PEEK Fusion Implant is threaded into the proximal phalanx and then it is press fit into the middle phalanx, allowing for reduction and fixation of the bone fragments.
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    K Number
    K133235
    Device Name
    THREADED PEEK K-WIRE
    Manufacturer
    MTP SOLUTIONS LLC
    Date Cleared
    2014-04-07

    (168 days)

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

    MTP SOLUTIONS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Threaded PEEK K-Wire is intended for use with suture in metatarsal ligament and tendon repairs.
    Device Description
    Threaded K-Wire is manufactured from PEEK and is 1.6 mm in diameter over its entire length. Both ends of the K-Wire are threaded, providing for two implants per device. The diameter of the pin allows it to function well with standard K-Wire drivers and the device is meant to be trimmed to length once in place.
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    K Number
    K133515
    Device Name
    PEEK FUSION IMPLANT
    Manufacturer
    MTP SOLUTIONS LLC
    Date Cleared
    2014-03-28

    (133 days)

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

    MTP SOLUTIONS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PEEK Fusion Implant is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.
    Device Description
    The PEEK Fusion Implant is manufactured from polyetheretone (PEEK) and is composed of two threaded components, each designed to engage either side of an osteotomy or reconstruction site. Once in position, the components mate with one another allowing for reduction and fixation of the bone fragments.
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    K Number
    K133229
    Device Name
    TITANIUM SUTURE ANCHOR
    Manufacturer
    MTP SOLUTIONS LLC
    Date Cleared
    2014-01-30

    (101 days)

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

    MTP SOLUTIONS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Titanium Suture Anchor is intended to be used for suture or tissue fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder. Specific indications are listed below: Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair. Capsular Shift or Capsulolabral Reconstruction Hand/Wrist: Scapholunate Ligament Reconstruction. Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair. Iliotibial Band Tenodesis Hip: Capsular repair, acetabular labral repair
    Device Description
    The Titanium Suture Anchor is a titanium alloy threaded device designed to attach soft tissues to bone when used in conjunction with suture.
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