Cleared Traditional

K082097 - DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE

K082097 is an FDA 510(k) clearance for DEMETECH POLYDIOXANONE SYNTHETIC MONOFI..., manufactured by Demetech Corp.. The device is a Class 2 General & Plastic Surgery device with product code NEW cleared through the Traditional 510(k) pathway after a 533-day FDA review.

K082097 · Demetech Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
533d
Days
Class 2
Risk

K082097 is an FDA 510(k) clearance for the DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE. Classified as Suture, Surgical, Absorbable, Polydioxanone (product code NEW), Class II - Special Controls.

Submitted by Demetech Corp. (Miami, US). The FDA issued a Cleared decision on January 8, 2010 after a review of 533 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

FDA 510(k) Submission Details - K082097

510(k) Number K082097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2008
Decision Date January 08, 2010
Days to Decision 533 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
418d slower than avg
Panel avg: 115d · This submission: 533d
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 66
Devices cleared under the same product code (NEW) and FDA review panel - the closest regulatory comparables to K082097.
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K080918 · Depuy Mitek · Apr 2008