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510(k) Data Aggregation
K Number
K113079Device Name
SYNTHES HEMOSTATIC BONE PUTTY
Manufacturer
SYNTHES (USA) PRODUCTS LLC/NORIAN CORPORATION
Date Cleared
2011-12-13
(57 days)
Product Code
MTJ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SYNTHES (USA) PRODUCTS LLC/NORIAN CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Synthes Hemostatic Bone Putty is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
Device Description
Synthes Hemostatic Bone Putty (HBP) stops bone bleeding by establishing a physical barrier along the edges of bones that have been damaged by trauma or cut during a surgical procedure. When applied as directed, HBP forms a mechanical barrier that occludes the vascular openings in the damaged bone. This barrier prevents further bleeding during the surgical procedure and dissolves postoperatively, permitting normal tissue healing and bone regeneration. HBP is a blend of synthetic water soluble polymers that form a ready-to-use hemostatic agent that is substantially eliminated from the defect site in less than 48 hours.
The constituents of Synthes Hemostatic Bone Putty and Ostene, the predicate, are similar. Ostene is comprised of a proprietary mixture of water soluble alkylene oxide copolymers. HBP is also comprised of water soluble alkylene oxide polymers. The remainder of HBP is a polysaccharide, carboxymethylcellulose (CMC), to improve handling. Ostene does not contain CMC.
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