Cleared Traditional

K002406 - MITEK 2GII MENISCAL REPAIR SYSTEM

K002406 is an FDA 510(k) clearance for MITEK 2GII MENISCAL REPAIR SYSTEM, manufactured by Mitek Products. The device is a Class 2 Orthopedic device with product code MAI cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K002406 · Mitek Products · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
192d
Days
Class 2
Risk

K002406 is an FDA 510(k) clearance for the MITEK 2GII MENISCAL REPAIR SYSTEM. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Mitek Products (Norwood, US). The FDA issued a Cleared decision on February 15, 2001 after a review of 192 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.

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FDA 510(k) Submission Details - K002406

510(k) Number K002406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2000
Decision Date February 15, 2001
Days to Decision 192 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
70d slower than avg
Panel avg: 122d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAI Device Classification - Class 2, Special Controls

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 214
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K002406.
ARTHREX BIO-POST AND WASHER
K011495 · Arthrex, Inc. · Aug 2001
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K011299 · Smith & Nephew, Inc. · Jun 2001
SUPER REVO SUTURE ANCHOR
K003984 · Linvatec Corp. · Mar 2001
SYNTHES MODIFIED BIORESORBABLE SUTURE ANCHOR SYSTEM
K003743 · Synthes (Usa) · Feb 2001
CONTOUR LABRAL NAIL, MODEL 533520A
K003970 · Bionx Implants, Inc. · Jan 2001
LACTOSORB SCREW ANCHOR
K003273 · Biomet, Inc. · Jan 2001