Cleared Traditional

K150209 - Healix BR Anchor

Also marketed or referenced as:
PanaLok RC QuickAnchor Plus Dual Suture, PanaLok RC QuickAnchor Plus w/Orthocord PanaLok RC QuickAnchor Plus Dual Suture w/Orthocord, PanaLok Loop Anchor, Lupine Loop Anchor, PanaLok RC Lop Anchor, BioKnotless Anchor, BioKnotless RC Anchor, RC Loop Anc

K150209 is the FDA 510(k) clearance for Healix BR Anchor by Depuy Mitek, A Johnson and Johnson Company. It is a Class 2 Orthopedic device (product code MAI) cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K150209 · Depuy Mitek, A Johnson and Johnson Company · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
249d
Days
Class 2
Risk

K150209 is an FDA 510(k) clearance for the Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR An.... Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Depuy Mitek, A Johnson and Johnson Company (Raynham, US). The FDA issued a Cleared decision on October 6, 2015 after a review of 249 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Depuy Mitek, A Johnson and Johnson Company devices

Submission Details

510(k) Number K150209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2015
Decision Date October 06, 2015
Days to Decision 249 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
127d slower than avg
Panel avg: 122d · This submission: 249d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 159
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K150209.
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K143660 · Depuy Mitek, A Johnson & Johnson Company · May 2015
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K143172 · Smith & Nephew, Inc. · Feb 2015