Cleared Traditional

K141084 - Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix

K141084 is an FDA 510(k) clearance for Matristem Surgery Matrix RS, 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 415-day FDA review.

K141084 · Acell, Inc. · General & Plastic Surgery device
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Jun 2015
Decision
415d
Days
Class 2
Risk

K141084 is an FDA 510(k) clearance for the Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix. 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 17, 2015 after a review of 415 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Acell, Inc. devices

FDA 510(k) Submission Details - K141084

510(k) Number K141084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2014
Decision Date June 17, 2015
Days to Decision 415 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
300d slower than avg
Panel avg: 115d · This submission: 415d
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 Peers - FTM Mesh, Surgical

All 125
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