Cleared Traditional

K103831 - DEPUY MITEK MILAGRO INTERFERENCE SCREW ...

K103831 is the FDA 510(k) clearance for DEPUY MITEK MILAGRO INTERFERENCE SCREW ... 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 203-day FDA review.

K103831 · Depuy Mitek, A Johnson & Johnson Company · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 2011
Decision
203d
Days
Class 2
Risk

K103831 is an FDA 510(k) clearance for the DEPUY MITEK MILAGRO INTERFERENCE SCREW MODEL 231803, 231804, 231807, 231809. 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 July 21, 2011 after a review of 203 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 & Johnson Company devices

Submission Details

510(k) Number K103831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2010
Decision Date July 21, 2011
Days to Decision 203 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
81d slower than avg
Panel avg: 122d · This submission: 203d
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 162
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K103831.
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K112249 · Depuy Mitek, A Johnson & Johnson Company · Oct 2011
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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
ARTHREX SWIVELOCK ANCHORS
K101823 · Arthrex, Inc. · Jan 2011