Cleared Traditional

HEALIX ADVANCE BR ANCHOR (K120078) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K120078 · Depuy Mitek Inc., Johnson and Johnson Company · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
50d
Days
Class 2
Risk

K120078 is an FDA 510(k) clearance for the HEALIX ADVANCE BR ANCHOR. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Depuy Mitek Inc., Johnson and Johnson Company (Raynham, US). The FDA issued a Cleared decision on February 29, 2012 after a review of 50 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Depuy Mitek Inc., Johnson and Johnson Company devices

Submission Details

510(k) Number K120078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2012
Decision Date February 29, 2012
Days to Decision 50 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
72d faster than avg
Panel avg: 122d · This submission: 50d
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 123
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K120078.
ARTHREX SUTURETAK SUTURE ANCHORS
K140855 · Arthrex, Inc. · Dec 2014
HEALICOIL SUTURE ANCHOR WITH REGENESORB
K123393 · Smith & Nephew, Inc. · Apr 2013
BIOBOLT
K120540 · Arthrex, Inc. · Mar 2012
ARTHREX BIOCOMPOSITE TRANSFIX
K112040 · Arthrex, Inc. · Dec 2011
ARTHREX BIOCOMPOSITE SUTURETAK
K110660 · Arthrex, Inc. · Mar 2011
OSTEORAPTOR II SUTURE ANCHOR OR TO BE DETERMINED MODEL: 72202764 72202765 72202766 72202767 72202768 72202769 72202770
K101459 · Smith & Nephew, Inc. · Jan 2011