Cleared Traditional

K040004 - ORTHOCORD SUTURE

K040004 is an FDA 510(k) clearance for ORTHOCORD SUTURE, manufactured by Depuy Mitek. The device is a Class 2 General & Plastic Surgery device with product code NEW cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K040004 · Depuy Mitek · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
102d
Days
Class 2
Risk

K040004 is an FDA 510(k) clearance for the 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 April 13, 2004 after a review of 102 days - within the typical 510(k) review window.

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. 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 Depuy Mitek devices

FDA 510(k) Submission Details - K040004

510(k) Number K040004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2004
Decision Date April 13, 2004
Days to Decision 102 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
13d faster than avg
Panel avg: 115d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 62
Devices cleared under the same product code (NEW) and FDA review panel - the closest regulatory comparables to K040004.
UNICRYL M
K042285 · United Medical Industries Co. , Ltd. · Dec 2004
BLUE ORTHOCORD SUTURE
K043298 · Depuy Mitek · Dec 2004
QUILL SYNTHETIC ABSORBABLE BARBED SUTURE
K042075 · Quill Medical, Inc. · Oct 2004
MONO-SWIFT
K030786 · Cp Medical · May 2003
PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P.
K022666 · Arc Medical Supplies (Beijing) Co, Ltd. · Oct 2002
MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE
K013274 · Cp Medical · Nov 2001