Cleared Special

K113534 - HEALIX KNOTLESS ANCHOR

K113534 is the FDA 510(k) clearance for HEALIX KNOTLESS ANCHOR by Depuy Mitek, A Johnson & Johnson Company. It is a Class 2 Orthopedic device (product code MAI) cleared through the Special 510(k) pathway after a 20-day FDA review.

K113534 · Depuy Mitek, A Johnson & Johnson Company · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
20d
Days
Class 2
Risk

K113534 is an FDA 510(k) clearance for the HEALIX KNOTLESS ANCHOR. 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 December 20, 2011 after a review of 20 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 K113534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2011
Decision Date December 20, 2011
Days to Decision 20 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 122d · This submission: 20d
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.

Regulatory Peers - MAI Fastener, Fixation, Biodegradable, Soft Tissue

All 158
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K113534.
MILAGRO INTERFERENCE SCREWS
K122869 · Depuy Mitek, A Johnson & Johnson Company · Dec 2012
MILAGRO INTERFERENCE SCREWS
K120589 · Depuy Mitek, A Johnson & Johnson Company · Apr 2012
BIOBOLT
K120540 · Arthrex, Inc. · Mar 2012
ARTHREX BIOCOMPOSITE TRANSFIX
K112040 · Arthrex, Inc. · Dec 2011
HEALIX KNOTLESS(TM) ANCHOR
K112249 · Depuy Mitek, A Johnson & Johnson Company · Oct 2011
DEPUY MITEK MILAGRO INTERFERENCE SCREW MODEL 231803, 231804, 231807, 231809
K103831 · Depuy Mitek, A Johnson & Johnson Company · Jul 2011