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510(k) Data Aggregation
K Number
K041421Device Name
NAME BONE VOID FILLER
Manufacturer
Date Cleared
2004-08-26
(90 days)
Product Code
Regulation Number
888.3045Why did this record match?
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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