Cleared Traditional

K120589 - MILAGRO INTERFERENCE SCREWS

K120589 is the FDA 510(k) clearance for MILAGRO INTERFERENCE SCREWS by Depuy Mitek, A Johnson & Johnson Company. It is a Class 2 Orthopedic device (product code MAI) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K120589 · Depuy Mitek, A Johnson & Johnson Company · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
56d
Days
Class 2
Risk

K120589 is an FDA 510(k) clearance for the MILAGRO INTERFERENCE SCREWS. 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 April 24, 2012 after a review of 56 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, A Johnson & Johnson Company devices

Submission Details

510(k) Number K120589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2012
Decision Date April 24, 2012
Days to Decision 56 days
Submission Type Traditional
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
66d faster than avg
Panel avg: 122d · This submission: 56d
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 158
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K120589.
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MILAGRO INTERFERENCE SCREWS
K122869 · Depuy Mitek, A Johnson & Johnson Company · Dec 2012
BIOBOLT
K120540 · Arthrex, Inc. · Mar 2012
HEALIX KNOTLESS ANCHOR
K113534 · Depuy Mitek, A Johnson & Johnson Company · Dec 2011
ARTHREX BIOCOMPOSITE TRANSFIX
K112040 · Arthrex, Inc. · Dec 2011