Cleared Traditional

K020279 - FOREX CORPORATION, OPTIMA, SPINAL SYSTEM

K020279 is an FDA 510(k) clearance for FOREX CORPORATION, manufactured by Forex Corp.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K020279 · Forex Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
143d
Days
Class 2
Risk

K020279 is an FDA 510(k) clearance for the FOREX CORPORATION, OPTIMA, SPINAL SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Forex Corp. (Murray, US). The FDA issued a Cleared decision on June 20, 2002 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 Forex Corp. devices

FDA 510(k) Submission Details - K020279

510(k) Number K020279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2002
Decision Date June 20, 2002
Days to Decision 143 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
21d slower than avg
Panel avg: 122d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNI Orthosis, Spinal Pedicle Fixation

All 235
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K020279.
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MODIFICATION TO TSRH SPINAL SYSTEM
K021106 · Medtronic Sofamor Danek, Inc. · May 2002
SYNTHES DUAL-OPENING USS
K020517 · Synthes (Usa) · Apr 2002