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510(k) Data Aggregation

    K Number
    K041421
    Device Name
    NAME BONE VOID FILLER
    Manufacturer
    Date Cleared
    2004-08-26

    (90 days)

    Product Code
    Regulation Number
    888.3045
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    Applicant Name (Manufacturer) :

    STRYKER BIOTECH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Stryker® TCP Putty is indicated as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. It is indicated for surgically created osseous defects or osseous defects resulting from traumatic injury. It should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. Stryker® TCP Putty is intended to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities, spine, and pelvis). Following placement in the bony void or gap, Stryker® TCP Putty is resorbed and replaced with bone during the healing process.
    Device Description
    Stryker® TCP Putty is an absorbable bone void filler composed of porous tri-calcium phosphate granules and carboxymethylcellulose, sodium (CMC) putty additive. It is an osteoconductive implant with a multidimensional porosity similar to human cancellous bone and acts as a scaffold for the in-growth of new bone and other connective tissues. The putty consistency allows the shape of the implant to conform to the defect, maximizing direct contact with viable host bone.
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