Cleared Traditional

K211178 - DURAMESH Mesh Suture (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence.

K211178 · Msi · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Sep 2022
Decision
500d
Days
Class 2
Risk

K211178 is an FDA 510(k) clearance for the DURAMESH Mesh Suture. Classified as Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), Class II - Special Controls.

Submitted by Msi (Chicago, US). The FDA issued a Cleared decision on September 2, 2022 after a review of 500 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 878.5010 - 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 Msi devices

Submission Details

510(k) Number K211178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2021
Decision Date September 02, 2022
Days to Decision 500 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
386d slower than avg
Panel avg: 114d · This submission: 500d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5010
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03940560 Withdrawn Interventional

Mesh Suture for Internal Load Bearing Closures

1
Site
Treatment
Purpose
Open label
Masking
Condition studied Suture; Complications, Mechanical; Suture; Complications, Infection or Inflammation; Suture, Complication
Study design Single group
Eligibility All sexes · 1 Year+
Principal investigator Garen Koloyan, MD PhD
Sponsor Wigmore Clinic
Started 2018-07-01 → Primary completion 2024-12-31 → Completed 2025-12-31
Primary outcome
Surgery healing complication, acute
Secondary outcome
Surgery healing complication, delayed
View full study on ClinicalTrials.gov

Regulatory Peers - GAW Suture, Nonabsorbable, Synthetic, Polypropylene

All 84
Devices cleared under the same product code (GAW) and FDA review panel - the closest regulatory comparables to K211178.
STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device
K253572 · Ethicon, Inc. · Mar 2026
Cypris eXact Suturing System
K233355 · Cypris Medical · Jan 2024
Non absorbable Surgical Polypropylene Suture
K230746 · Shandong Haidike Medical Products Co., Ltd. · Sep 2023
Vesseal
K221280 · Lydus Medical , Ltd. · Dec 2022