Cleared Traditional

K123362 - MILAGRO ADVANCE INTERFERENCE SCREW

K123362 is the FDA 510(k) clearance for MILAGRO ADVANCE INTERFERENCE SCREW by Depuy Mitek, A Johnson & Johnson Company. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K123362 · Depuy Mitek, A Johnson & Johnson Company · Orthopedic device
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Feb 2013
Decision
92d
Days
Class 2
Risk

K123362 is an FDA 510(k) clearance for the MILAGRO ADVANCE INTERFERENCE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Depuy Mitek, A Johnson & Johnson Company (Raynham, US). The FDA issued a Cleared decision on February 1, 2013 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 & Johnson Company devices

Submission Details

510(k) Number K123362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2012
Decision Date February 01, 2013
Days to Decision 92 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
30d faster than avg
Panel avg: 122d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
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 - HWC Screw, Fixation, Bone

All 554
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K123362.
MEDLINE CANNULATED SCREW
K130319 · Medline Industries, Inc. · May 2013
AAP CANNULATED SCREW 2.0
K130590 · Aap Implantate AG · Apr 2013
ACUMED CANNULATED SCREW SYSTEM
K123890 · Acumed, LLC · Mar 2013
ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS
K122596 · Smith & Nephew, Inc. · Nov 2012
PRO-TOE(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITION
K120645 · Wrightmedicaltechnologyinc · Apr 2012
ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY
K112885 · Zimmer, Inc. · Dec 2011