Cleared Traditional

K024096 - OPTIMA, SPINAL SYSTEM

K024096 is an FDA 510(k) clearance for OPTIMA, manufactured by U&I Corp., America. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K024096 · U&I Corp., America · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
90d
Days
Class 2
Risk

K024096 is an FDA 510(k) clearance for the OPTIMA, SPINAL SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by U&I Corp., America (Murray, US). The FDA issued a Cleared decision on March 12, 2003 after a review of 90 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 U&I Corp., America devices

FDA 510(k) Submission Details - K024096

510(k) Number K024096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2002
Decision Date March 12, 2003
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 228
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K024096.
MODIFICATION TO HORIZON SPINAL SYSTEM
K030840 · Medtronic Sofamor Danek, Inc. · May 2003
BLACKSTONE SPINAL FIXATION SYSTEM RIGID CROSS CONNECTOR
K030862 · Blackstone Medical, Inc. · Apr 2003
SYNTHES USS, CLICK'X, USS VAS, DUAL-OPENING USS AND SMALL STATURE USS
K022949 · Synthes (Usa) · Mar 2003
MODIFICATION TO SYNTHES CERVIFIX SYSTEM
K030377 · Synthes (Usa) · Mar 2003
SUMMIT OCT SPINAL SYSTEM MINIPOLYAXIAL SCREWS
K030103 · Depuyacromed · Feb 2003
ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM
K023299 · Alphatec Mfg., Inc. · Dec 2002