Cleared Special

K150438 - Force Fiber OrthoTape suture

K150438 is an FDA 510(k) clearance for Force Fiber OrthoTape suture, manufactured by Teleflexmedical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAT cleared through the Special 510(k) pathway after a 42-day FDA review.

K150438 · Teleflexmedical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
42d
Days
Class 2
Risk

K150438 is an FDA 510(k) clearance for the Force Fiber OrthoTape suture. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Teleflexmedical, Inc. (Mansfield, US). The FDA issued a Cleared decision on April 2, 2015 after a review of 42 days - a notably fast clearance cycle.

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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K150438

510(k) Number K150438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2015
Decision Date April 02, 2015
Days to Decision 42 days
Submission Type Special
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
73d faster than avg
Panel avg: 115d · This submission: 42d
Pathway characteristics
Modification to existing cleared device.

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 Peers - GAT Suture, Nonabsorbable, Synthetic, Polyethylene

All 175
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K150438.
Stryker Suture Tape
K150584 · Stryker · Aug 2015
NovoStitch Plus Meniscal Repair System
K143356 · Ceterix Orthopaedics, Inc. · Jul 2015
Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2
K150327 · Dunamis, LLC · Jun 2015
LARIAT sulture Delivery Device
K142241 · Sentreheart, Inc. · Sep 2014
SUPOLENE
K141072 · Resorba Medical GmbH · Jun 2014
A.I.M. KNOTLESS MENISCAL REPAIR DEVICE
K133770 · Anchor Innovation Medical (A.I.M.) · Jun 2014
K150438 · Force Fiber OrthoTape suture
Download PDF FDA Summary Teleflexmedical, Inc.