Cleared Traditional

ISOLOCK SPINAL SYSTEM (K990721) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K990721 · Scien'Tx USA, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
83d
Days
Class 2
Risk

K990721 is an FDA 510(k) clearance for the ISOLOCK 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 May 27, 1999 after a review of 83 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

Submission Details

510(k) Number K990721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1999
Decision Date May 27, 1999
Days to Decision 83 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
39d faster than avg
Panel avg: 122d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 39
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K990721.
SOCON SPINAL SYSTEM
K993551 · Aesculap, Inc. · Jan 2000
OSTEONICS SPINAL SYSTEM- ROD/ PLATE SYSTEM
K991055 · Howmedica Osteonics Corp. · Aug 1999
SYNTHES PEDIATRIC ROD SYSTEM
K991552 · Synthes (Usa) · Jun 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
TITANIUM SPINAL ROD SYSTEM
K980862 · United States Surgical, A Division of Tyco Healthc · May 1998