Cleared Special

K130422 - PHANTOM FIBER BIOFIBER SUTURE (FDA 510(k) Clearance)

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

K130422 · Tornier, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Apr 2013
Decision
43d
Days
Class 2
Risk

K130422 is an FDA 510(k) clearance for the PHANTOM FIBER BIOFIBER SUTURE. Classified as Suture, Recombinant Technology (product code NWJ), Class II - Special Controls.

Submitted by Tornier, Inc. (Bloomington, US). The FDA issued a Cleared decision on April 4, 2013 after a review of 43 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4494 - 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.

View all Tornier, Inc. devices

Submission Details

510(k) Number K130422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2013
Decision Date April 04, 2013
Days to Decision 43 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
72d faster than avg
Panel avg: 115d · This submission: 43d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NWJ Suture, Recombinant Technology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4494
Definition Intended For Use In Soft Tissue Approximation. Indicated For Use In General Soft Tissue Approximation And/or Ligation.
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.