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510(k) Data Aggregation

    K Number
    K141920
    Device Name
    Wrist Hemiarthroplasty System
    Manufacturer
    ARTHROSURFACE, INC.
    Date Cleared
    2014-12-23

    (160 days)

    Product Code
    KWN, KWO
    Regulation Number
    888.3750
    Why did this record match?
    Product Code :

    KWN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated for use as a partial replacement of wrist joint(s) disabled by pain, deformity and/or limited motion caused by: - Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis and avascular necrosis - Rheumatoid arthritis . - Revision where other devices or treatments have failed ● - Scapholunate Advanced Collapse (SLAC) and other functional deformities ● - Trauma, including fractures of the carpal bones ● The device is a single use implant intended to be used with bone cement.
    Device Description
    The Arthrosurface HemiCAP® Wrist Hemiarthroplasty System consists of a contoured articular implant designed to articulate with the natural radius bone, a taper post and set of instruments used for implant site preparation and delivery. The resurfacing components are manufactured using implant grade cobalt-chrome alloy and will be offered in two diameters, and four articular radii. The taper post is manufactured using implant grade titanium alloy and is offered in one fixed size designed to work with all resurfacing implants.
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    K Number
    K080997
    Device Name
    ASCENSION PYROCARBON LUNATE
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Date Cleared
    2008-06-17

    (70 days)

    Product Code
    KWN
    Regulation Number
    888.3750
    Why did this record match?
    Product Code :

    KWN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ascension® PyroCarbon Lunate is intended for replacement of the lunate bone in the proximal carpal row of the wrist in the presence of: - Avascular necrosis (Kienboch's disease) . - Localized osteoarthritic changes - Long-Standing dislocations .
    Device Description
    The Ascension® PyroCarbon Lunate is an anatomically designed lunate replacement with essentially the same shape as the native lunate bone. The Lunate implant acts as an articulating spacer to maintain the relationship of adjacent carpal bones after excision and to maintain mobility of the wrist. The articular concavity that captures the capitate is more exaggerated to enhance stability. The Lunate implant has two suture holes that allow fixation of the implant to the adjacent scaphoid and triquetrium bones to provide temporary postoperative stability while a capsuloligamentous system forms around the implant. The Ascension Pyrocarbon Lunate is constructed of a high strength On-X® PyroCarbon layer deposited on a graphite substrate. The graphite is impregnated with tungsten making the Lunate implant radiopaque. The Ascension Pyrocarbon Lunate is available in 5 sizes for use in left or right applications. Device components are provided sterile in individual packaging.
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    K Number
    K050028
    Device Name
    MAESTRO CARPAL HEMIARTHROPLASTY
    Manufacturer
    BIOMET MANUFACTURING, INC.
    Date Cleared
    2005-03-25

    (78 days)

    Product Code
    KWN, KWO
    Regulation Number
    888.3750
    Why did this record match?
    Product Code :

    KWN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Maestro™ Carpal HemiArthroplasty is indicated for use as a replacement of wrist joints disabled by pain, deformity and/or limited motion caused by: 1) Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis and avascular necrosis 2) Rheumatoid arthritis 3) Revision where other devices or treatments have failed 4) Scapholunate Advanced Collapse (SLAC) and other functional deformities 5) Trauma, including fractures of the carpal bones The device is intended to be implanted with bone cement.
    Device Description
    The Maestro™ Carpal HemiArthroplasty is a three piece carpal component designed to articulate with the natural radial bone. The carpal component consists of 3 sub-components - a carpal head, a carpal plate and a capitate stem. The carpal head comes in 3 heights, standard, +2 and +4. This allows the surgeon to adjust for soft tissue laxity. Two lengths of carpal plates give the surgeon options of screw placement.
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