Cleared Special

K043298 - BLUE ORTHOCORD SUTURE

K043298 is an FDA 510(k) clearance for BLUE ORTHOCORD SUTURE, manufactured by Depuy Mitek. The device is a Class 2 General & Plastic Surgery device with product code NEW cleared through the Special 510(k) pathway after a 10-day FDA review.

K043298 · Depuy Mitek · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Dec 2004
Decision
10d
Days
Class 2
Risk

K043298 is an FDA 510(k) clearance for the BLUE ORTHOCORD SUTURE. Classified as Suture, Surgical, Absorbable, Polydioxanone (product code NEW), Class II - Special Controls.

Submitted by Depuy Mitek (Norwood, US). The FDA issued a Cleared decision on December 10, 2004 after a review of 10 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4840 - 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 Depuy Mitek devices

FDA 510(k) Submission Details - K043298

510(k) Number K043298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2004
Decision Date December 10, 2004
Days to Decision 10 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
105d faster than avg
Panel avg: 115d · This submission: 10d
Pathway characteristics
Modification to existing cleared device.

NEW Device Classification - Class 2, Special Controls

Product Code NEW Suture, Surgical, Absorbable, Polydioxanone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4840
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 - NEW Suture, Surgical, Absorbable, Polydioxanone

All 31
Devices cleared under the same product code (NEW) and FDA review panel - the closest regulatory comparables to K043298.
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K061037 · Ethicon, Inc. · Jul 2006
MONO-SWIFT
K030786 · Cp Medical · May 2003
MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE
K013274 · Cp Medical · Nov 2001