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510(k) Data Aggregation
K Number
K150064Device Name
Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15)
Manufacturer
Date Cleared
2015-09-04
(234 days)
Product Code
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
ORTHOGEM LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
TriPore HA, TriPore BP90, TriPore BP15, is a synthetic bone graft intended to be packed into bone defects of the sketal system (extremities, posterolateral spine, or pelvis) which are not intrinsic to the stability of the bony structure. These defects may be surgically created voids or from traumatic injury to the bone. The device gradually resorbs and is replaced with bone during the healing process. Rigid fixation techniques should be used in conjunction with this device.
Device Description
Synthetic bone graft granules of one of the following three materials packed in a multi-purpose applicator (MPA):
(A) 100% pure hydroxylapatite (TriPore HA)
(B) biphasic mixture of 90% hydroxyapatite and 10% tri-calcium phosphate (TriPore BP90)
(C) biphasic mixture of 15% hydroxyapatite and 85% tri-calcium phosphate (TriPore BP15)
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