Cleared Traditional

K041333 - SYNTHES (USA) TITANIUM WIRE

K041333 is an FDA 510(k) clearance for 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 100-day FDA review.

K041333 · Synthes (Usa) · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
100d
Days
Class 2
Risk

K041333 is an FDA 510(k) clearance for the 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 August 27, 2004 after a review of 100 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. 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 - K041333

510(k) Number K041333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2004
Decision Date August 27, 2004
Days to Decision 100 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
15d faster than avg
Panel avg: 115d · This submission: 100d
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 K041333.
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
MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE
K042606 · Synthes (Usa) · May 2005
SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE
K032468 · Suturtek Incorporated · Sep 2003
TENO FIX
K023594 · Ortheon Medical, LLC · May 2003
STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE
K030351 · Cp Medical · Mar 2003
K041333 · SYNTHES (USA) TITANIUM WIRE
Download PDF FDA Summary Synthes (Usa)