Cleared Special

K080918 - DOUBLE ARMED MENISCAL NEEDLES WITH SIZE...

K080918 is an FDA 510(k) clearance for DOUBLE ARMED MENISCAL NEEDLES WITH SIZE..., 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 22-day FDA review.

K080918 · Depuy Mitek · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
22d
Days
Class 2
Risk

K080918 is an FDA 510(k) clearance for the DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENISCAL NEEDLE WITH .... Classified as Suture, Surgical, Absorbable, Polydioxanone (product code NEW), Class II - Special Controls.

Submitted by Depuy Mitek (Raynham, US). The FDA issued a Cleared decision on April 23, 2008 after a review of 22 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 - K080918

510(k) Number K080918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2008
Decision Date April 23, 2008
Days to Decision 22 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
93d faster than avg
Panel avg: 115d · This submission: 22d
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 K080918.
DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX
K120284 · Coloplast A/S · May 2012
PDS(TM) BARBED SUTURES
K113004 · Ethicon, Inc. · Dec 2011
PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT
K100461 · Riverpoint Medical · Jul 2010
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