Cleared Traditional

K150327 - Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2

K150327 is an FDA 510(k) clearance for Dunamis Force DFX Suture, manufactured by Dunamis, LLC. The device is a Class 2 General & Plastic Surgery device with product code GAT cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K150327 · Dunamis, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K150327

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
Combination Product No
PCCP Authorized No
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.

GAT Device Classification - Class 2, Special Controls

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 Consultant

Lexamed
Robert O Dean

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 - GAT Suture, Nonabsorbable, Synthetic, Polyethylene

All 141
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K150327.
Nexus Suture
K151009 · Baylis Medical Company, Inc. · Aug 2015
Stryker Suture Tape
K150584 · Stryker · Aug 2015
NovoStitch Plus Meniscal Repair System
K143356 · Ceterix Orthopaedics, Inc. · Jul 2015
Force Fiber OrthoTape suture
K150438 · Teleflexmedical, Inc. · Apr 2015
LARIAT sulture Delivery Device
K142241 · Sentreheart, Inc. · Sep 2014
SUPOLENE
K141072 · Resorba Medical GmbH · Jun 2014