Cleared Special

K131974 - HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM) (FDA 510(k) Clearance)

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

K131974 · Depuy Mitek, A Johnson & Johnson Company · Orthopedic device

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Jul 2013

Decision

27d

Days

Class 2

Risk

K131974 is an FDA 510(k) clearance for the HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM). Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Depuy Mitek, A Johnson & Johnson Company (Raynham, US). The FDA issued a Cleared decision on July 25, 2013 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory 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	K131974 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 28, 2013
Decision Date	July 25, 2013
Days to Decision	27 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

95d faster than avg

Panel avg: 122d · This submission: 27d

Pathway characteristics

Modification to existing cleared device.

Device Classification

Product Code	MAI Fastener, Fixation, Biodegradable, Soft Tissue
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 888.3030

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 Orthopedic devices follow this clearance model.