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510(k) Data Aggregation
K Number
K162461Device Name
Endoform Plastics and Reconstructive Matrix
Manufacturer
AROA BIOSURGERY (FORMERLY MESYNTHES LIMITED)
Date Cleared
2016-12-20
(109 days)
Product Code
FTM
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
AROA BIOSURGERY (FORMERLY MESYNTHES LIMITED)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Endoform® Plastics and Reconstructive Matrix is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.
Device Description
Endoform® Plastics and Reconstructive Matrix is an advanced collagen matrix comprised of natural >70%, non-reconstituted collagen. Endoform® Plastics and Reconstructive Matrix is designed to be fixed, via sutures, staples or tacks to the surrounding tissue, at the discretion of the attending physician for applications in plastic and reconstructive surgery. For example, the device can be surgically implanted to reinforce damaged or ruptured soft tissue membranes and reinforce muscle flaps. The device is supplied sterile and dry in a variety of sizes and thicknesses, which can be trimmed by surgeons to meet the individual patient's needs. Endoform® Plastics and Reconstructive Matrix is laminated via a proprietary process termed 'lug lamination', which is a physical means of fabricating the devices, such that the individual sheets of the device are physically bonded to one another as opposed to using embroidery to sew the laminate of collagen matrix sheets.
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