Cleared Traditional

K170763 - Gentrix Surgical Matrix Thick

Also marketed or referenced as:
Gentrix Surgical Matrix Extend

K170763 is an FDA 510(k) clearance for Gentrix Surgical Matrix Thick, manufactured by Acell, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTM cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K170763 · Acell, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
87d
Days
Class 2
Risk

K170763 is an FDA 510(k) clearance for the Gentrix Surgical Matrix Thick. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Acell, Inc. (Columbia, US). The FDA issued a Cleared decision on June 8, 2017 after a review of 87 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Acell, Inc. devices

FDA 510(k) Submission Details - K170763

510(k) Number K170763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2017
Decision Date June 08, 2017
Days to Decision 87 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 115d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTM Device Classification - Class 2, Special Controls

Product Code FTM Mesh, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
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.

Regulatory Consultant

Hogan Lovells US LLP
John J. Smith

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FTM Mesh, Surgical

All 76
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K170763.
Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal
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