Cleared Special

K140127 - FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP

K140127 is an FDA 510(k) clearance for FERROFIBRE STAINLESS STEEL SUTURE WITH ..., manufactured by Pontis Orthopaedics, LLC. The device is a Class 2 General & Plastic Surgery device with product code GAQ cleared through the Special 510(k) pathway after a 132-day FDA review.

K140127 · Pontis Orthopaedics, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
132d
Days
Class 2
Risk

K140127 is an FDA 510(k) clearance for the FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP. Classified as Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile (product code GAQ), Class II - Special Controls.

Submitted by Pontis Orthopaedics, LLC (San Francisco, US). The FDA issued a Cleared decision on May 28, 2014 after a review of 132 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4495 - 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. Standard predicate reliance. 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 - K140127

510(k) Number K140127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2014
Decision Date May 28, 2014
Days to Decision 132 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
17d slower than avg
Panel avg: 115d · This submission: 132d
Pathway characteristics
Modification to existing cleared device.

GAQ Device Classification - Class 2, Special Controls

Product Code GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4495
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 - GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

All 31
Devices cleared under the same product code (GAQ) and FDA review panel - the closest regulatory comparables to K140127.
MERISTEEL
K172146 · M/s. Meril Endo Surgery Private Limited. · Feb 2018
Surgical Stainless Steel Suture, Stainless Steel Suture
K170767 · Ethicon, Inc. · Nov 2017
DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE
K141007 · Demetech Corp. · Sep 2014
FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5
K081060 · Core Essence Orthopaedics, LLC · Dec 2008
SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE
K082828 · Suturtek Incorporated · Oct 2008
SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17
K063603 · Suturtek Incorporated · Feb 2007
K140127 · FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP
Download PDF FDA Summary Pontis Orthopaedics, …