Cleared Traditional

K053380 - CONTOUR THREAD SYNTHETIC ABSORBABLE PDO...

K053380 is an FDA 510(k) clearance for CONTOUR THREAD SYNTHETIC ABSORBABLE PDO..., manufactured by Surgical Specialties Corp. The device is a Class 2 General & Plastic Surgery device with product code NEW cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K053380 · Surgical Specialties Corp · General & Plastic Surgery device
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Jan 2006
Decision
44d
Days
Class 2
Risk

K053380 is an FDA 510(k) clearance for the CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE. Classified as Suture, Surgical, Absorbable, Polydioxanone (product code NEW), Class II - Special Controls.

Submitted by Surgical Specialties Corp (Reading, US). The FDA issued a Cleared decision on January 18, 2006 after a review of 44 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Surgical Specialties Corp devices

FDA 510(k) Submission Details - K053380

510(k) Number K053380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2005
Decision Date January 18, 2006
Days to Decision 44 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
71d faster than avg
Panel avg: 115d · This submission: 44d
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 35
Devices cleared under the same product code (NEW) and FDA review panel - the closest regulatory comparables to K053380.
QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGICAL SUTURE MATERIAL
K071989 · Surgical Specialties Corp · Aug 2007
SHARPOINT PDO (POLYDIOXANONE) SUTURES
K063680 · Surgical Specialties Corp · May 2007
PDS PLUS ANTIBACTERIAL SUTURE
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