Cleared Special

K021379 - SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06

K021379 is an FDA 510(k) clearance for SCS CLARIS SPINAL SYSTEM, manufactured by Ortho Tec, LLC. The device is a Class 2 Orthopedic device with product code MNI cleared through the Special 510(k) pathway after a 30-day FDA review.

K021379 · Ortho Tec, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
30d
Days
Class 2
Risk

K021379 is an FDA 510(k) clearance for the SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Ortho Tec, LLC (Chesterland, US). The FDA issued a Cleared decision on May 31, 2002 after a review of 30 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.

FDA 510(k) Submission Details - K021379

510(k) Number K021379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2002
Decision Date May 31, 2002
Days to Decision 30 days
Submission Type Special
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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 302
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K021379.
MODIFICATION TO SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
K022190 · Depuyacromed · Jul 2002
MICOMED POSTERIOR DOUBLEROD SYSTEM
K021275 · Micomed Ortho GmbH · Jul 2002
FOREX CORPORATION, OPTIMA, SPINAL SYSTEM
K020279 · Forex Corp. · Jun 2002
MODIFICATION TO TSRH SPINAL SYSTEM
K021106 · Medtronic Sofamor Danek, Inc. · May 2002
SYNTHES DUAL-OPENING USS
K020517 · Synthes (Usa) · Apr 2002
UNI-T SPINAL SYSTEM
K013301 · Spine Vision, Inc. · Feb 2002
K021379 · SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06
Download PDF FDA Summary Ortho Tec, LLC