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510(k) Data Aggregation
K Number
K181094Device Name
Polydioxanone Surgical Scaffold
Manufacturer
lntegra LifeSciences
Date Cleared
2018-08-02
(99 days)
Product Code
FTL, OWT
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
lntegra LifeSciences
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Polydioxanone Surgical Scaffold is indicated for use in reinforcement of soft tissue where weakness exists.
Device Description
Polydioxanone Surgical Scaffold™ is a resorbable, colorless, monofilament knit surgical mesh. Polydioxanone Surgical Scaffold™ is packaged individually and is provided sterile as a flat mesh that can be cut to the desired shape and size. Polydioxanone Surgical Scaffold™ is made entirely of uncolored and undyed polydioxanone (PDO) thread, which is similar in form to PDO sutures. The threads degrade via bulk hydrolysis once implanted. Strength retention decreases followed by mass loss in the threads. In vitro degradation studies show that Polydioxanone Surgical Scaffold™ threads retain some burst strength for 3 months, but not beyond that time. In vivo implantation studies in swine demonstrate that Polydioxanone Surgical Scaffold™ takes up to 9 months to fully absorb.
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