Cleared Special

FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP (K140127) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K140127 · Pontis Orthopaedics, LLC · General & Plastic Surgery device
Download Printable Device Report (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.

View all Pontis Orthopaedics, LLC devices

Submission Details

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
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 115d · This submission: 132d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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
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