Cleared Traditional

K990118 - ISOBAR SPINAL SYSTEM

K990118 is an FDA 510(k) clearance for ISOBAR SPINAL SYSTEM, manufactured by Scien'Tx USA, Inc.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K990118 · Scien'Tx USA, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
68d
Days
Class 2
Risk

K990118 is an FDA 510(k) clearance for the 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 March 22, 1999 after a review of 68 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Scien'Tx USA, Inc. devices

FDA 510(k) Submission Details - K990118

510(k) Number K990118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1999
Decision Date March 22, 1999
Days to Decision 68 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
54d faster than avg
Panel avg: 122d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 203
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K990118.
MODIFICATION TO TENOR SPINAL SYSTEM-PLATES
K991364 · Sofamor Danek USA,Inc. · May 1999
MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM
K991460 · Sofamor Danek · May 1999
TRIFIX PEDICLE SPINAL SCREW ASSEMBLY
K990657 · Corin USA · Mar 1999
OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS
K984302 · Osteonics Corp. · Dec 1998
OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWS
K983152 · Osteonics Corp. · Sep 1998
SYNTHES SPINE PEDIATRIC ROD SYSTEM
K980761 · Synthes Spine · Aug 1998