Cleared Traditional

Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2 (K150327) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K150327 · Dunamis, LLC · General & Plastic Surgery device
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Jun 2015
Decision
139d
Days
Class 2
Risk

K150327 is an FDA 510(k) clearance for the Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Dunamis, LLC (Greenville, US). The FDA issued a Cleared decision on June 29, 2015 after a review of 139 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5000 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Dunamis, LLC devices

Submission Details

510(k) Number K150327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2015
Decision Date June 29, 2015
Days to Decision 139 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 115d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5000
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 - GAT Suture, Nonabsorbable, Synthetic, Polyethylene

All 173
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K150327.
Polyethylene
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HyperSuture All Green Extension Line
K254275 · Threadstone, LLC · Mar 2026
Meniscus Versaflex
K254188 · GM Dos Reis Industria e Comercio Ltda. · Feb 2026
Pre-Sutured Tendon
K253145 · Rti Surgical, Inc. · Oct 2025
ProZip Knotless Implant
K253024 · Riverpoint Medical · Oct 2025
PowerKnot High Strength Sutures
K252225 · Medacta International S.A. · Sep 2025