Cleared Special

K142574 - 4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, (FDA 510(k) Clearance)

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

K142574 · Depuy Mitek, A Johnson & Johnson Company · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2014
Decision
42d
Days
Class 2
Risk

K142574 is an FDA 510(k) clearance for the 4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Hea.... Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Depuy Mitek, A Johnson & Johnson Company (Raynham, US). The FDA issued a Cleared decision on October 24, 2014 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 K142574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2014
Decision Date October 24, 2014
Days to Decision 42 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
80d faster than avg
Panel avg: 122d · This submission: 42d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 590
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