Cleared Special

K050771 - LUPINE LOOP (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K050771 · Depuy Mitek, A Johnson & Johnson Company · General & Plastic Surgery device

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Optimized for regulatory review, auditing and printing

Apr 2005

Decision

14d

Days

Class 2

Risk

K050771 is an FDA 510(k) clearance for the LUPINE LOOP. Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Depuy Mitek, A Johnson & Johnson Company (Norwood, US). The FDA issued a Cleared decision on April 8, 2005 after a review of 14 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4493 - 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, A Johnson & Johnson Company devices

Submission Details

510(k) Number	K050771 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 25, 2005
Decision Date	April 08, 2005
Days to Decision	14 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

100d faster than avg

Panel avg: 114d · This submission: 14d

Pathway characteristics

Modification to existing cleared device.

Device Classification

Product Code	GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 878.4493

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.