Cleared Special

K020245 - MODIFICATION TO ISOBAR SPINAL SYSTEM

K020245 is an FDA 510(k) clearance for MODIFICATION TO ISOBAR SPINAL SYSTEM, manufactured by Scien'Tx USA, Inc.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Special 510(k) pathway after a 8-day FDA review.

K020245 · Scien'Tx USA, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
8d
Days
Class 2
Risk

K020245 is an FDA 510(k) clearance for the MODIFICATION TO ISOBAR SPINAL SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Scien'Tx USA, Inc. (Austin, US). The FDA issued a Cleared decision on February 1, 2002 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Scien'Tx USA, Inc. devices

FDA 510(k) Submission Details - K020245

510(k) Number K020245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2002
Decision Date February 01, 2002
Days to Decision 8 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 122d · This submission: 8d
Pathway characteristics
Modification to existing cleared device.

MNH Device Classification - Class 2, Special Controls

Product Code MNH Orthosis, Spondylolisthesis Spinal 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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 204
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K020245.
EBI OMEGA21 SPINAL FIXATION SYSTEM
K020681 · Ebi, L.P. · Apr 2002
OSTEONICS SPINAL SYSTEM
K020293 · Howmedica Osteonics Corp. · Feb 2002
BACFIX SPINAL FIXATION SYSTEM
K013887 · Spinal Concepts, Inc. · Feb 2002
MODIFICATION TO OPUS SPINAL SYSTEM
K014229 · Howmedica Osteonics Corp. · Jan 2002
MODIFICATION TO EBI OMEGA 21 SYSTEM
K014137 · Ebi, L.P. · Jan 2002
MODIFICATION TO TSRH SPINAL SYSTEM
K014076 · Medtronic Sofamor Danek, Inc. · Dec 2001