Cleared Traditional

K042606 - MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE

K042606 is an FDA 510(k) clearance for MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE, manufactured by Synthes (Usa). The device is a Class 2 General & Plastic Surgery device with product code GAQ cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K042606 · Synthes (Usa) · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
245d
Days
Class 2
Risk

K042606 is an FDA 510(k) clearance for the MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE. Classified as Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile (product code GAQ), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on May 27, 2005 after a review of 245 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.

FDA 510(k) Submission Details - K042606

510(k) Number K042606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2004
Decision Date May 27, 2005
Days to Decision 245 days
Submission Type Traditional
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
130d slower than avg
Panel avg: 115d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K042606.
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
SYNTHES (USA) TITANIUM WIRE
K041333 · Synthes (Usa) · Aug 2004
SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE
K032468 · Suturtek Incorporated · Sep 2003
TENO FIX
K023594 · Ortheon Medical, LLC · May 2003
K042606 · MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE
Download PDF FDA Summary Synthes (Usa)