Cleared Traditional

K040493 - OUTOLOGOUS SPINAL FIXATION SYSTEM

K040493 is an FDA 510(k) clearance for OUTOLOGOUS SPINAL FIXATION SYSTEM, manufactured by Orthopedic Sciences, Inc.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K040493 · Orthopedic Sciences, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Sep 2004
Decision
190d
Days
Class 2
Risk

K040493 is an FDA 510(k) clearance for the OUTOLOGOUS SPINAL FIXATION SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Orthopedic Sciences, Inc. (San Diego, US). The FDA issued a Cleared decision on September 3, 2004 after a review of 190 days - an extended review cycle.

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 Orthopedic Sciences, Inc. devices

FDA 510(k) Submission Details - K040493

510(k) Number K040493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2004
Decision Date September 03, 2004
Days to Decision 190 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
68d slower than avg
Panel avg: 122d · This submission: 190d
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 194
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K040493.
MODIFICATION TO EQUATION FIXATION SYSTEM
K042453 · Medtronic Sofamor Danek, Inc. · Oct 2004
MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM
K042514 · Blackstone Medical, Inc. · Oct 2004
BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR
K042100 · Blackstone Medical, Inc. · Sep 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K041777 · Medtronic Sofamor Danek · Sep 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K041030 · Medtronic Sofamor Danek · Jun 2004
SUMMIT OCT SPINAL SYSTEM
K041203 · Depuy Spine, Inc. · Jun 2004