Cleared Traditional

TENO FIX (K023594) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K023594 · Ortheon Medical, LLC · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
May 2003
Decision
202d
Days
Class 2
Risk

K023594 is an FDA 510(k) clearance for the TENO FIX. Classified as Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile (product code GAQ), Class II - Special Controls.

Submitted by Ortheon Medical, LLC (Washington, US). The FDA issued a Cleared decision on May 15, 2003 after a review of 202 days - an extended review cycle.

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. 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 Ortheon Medical, LLC devices

Submission Details

510(k) Number K023594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2002
Decision Date May 15, 2003
Days to Decision 202 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 115d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 10
Devices cleared under the same product code (GAQ) and FDA review panel - the closest regulatory comparables to K023594.
Surgical Stainless Steel Suture, Stainless Steel Suture
K170767 · Ethicon, Inc. · Nov 2017
MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE
K042606 · Synthes (Usa) · May 2005
SYNTHES (USA) TITANIUM WIRE
K041333 · Synthes (Usa) · Aug 2004
STEELEX STERNUM SET
K023411 · Aesculap, Inc. · Dec 2002
STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK
K946173 · Ethicon, Inc. · Jan 1995
ETHI-PACK* SURGICAL STAINLESS STEEL SUTURE
K931271 · Ethicon, Inc. · Jan 1994