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510(k) Data Aggregation
K Number
K171037Device Name
PoreStar Patient Specific Implant
Manufacturer
Anatomics Pty Ltd
Date Cleared
2017-12-27
(265 days)
Product Code
JOF, GWO
Regulation Number
874.3620Why did this record match?
Applicant Name (Manufacturer) :
Anatomics Pty Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PoreStar Patient Specific Implant is intended for the augmentation or restoration of bony contour in craniofacial defects.
Device Description
The PoreStar Patient Specific Implants are a range of anatomically shaped, patient specific surgical implants manufactured from high density polyethylene (HDPE) to the reconstructive boundaries indicated by the surgeon. The interconnecting porous ("Pore-") architecture created from a star ("-Star”) shaped particle resembles trabecular bone and permits tissue ingrowth into the implant. PoreStar Patient Specific Implants are individually designed from 3D Computed Tomography (CT) scans provided to Anatomics by the referring surgeon. The PoreStar Patient Specific Implants are provided sterile and intended for single-use.
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