Cleared Special

K171357 - SurgiMend PRS Meshed, Revize-X (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K171357 · Integra Lifesciences Corporation (Owner of Tei Biosciences) · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jun 2017
Decision
29d
Days
Class 2
Risk

K171357 is an FDA 510(k) clearance for the SurgiMend PRS Meshed, Revize-X. Classified as Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery (product code OXH), Class II - Special Controls.

Submitted by Integra Lifesciences Corporation (Owner of Tei Biosciences) (Boston, US). The FDA issued a Cleared decision on June 7, 2017 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Integra Lifesciences Corporation (Owner of Tei Biosciences) devices

Submission Details

510(k) Number K171357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2017
Decision Date June 07, 2017
Days to Decision 29 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 114d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OXH Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition For Reinforcement Of Soft Tissue Where Weakness Exists In Plastic And Reconstructive Surgery.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.