Cleared Special

SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDIUM, MODEL CO05, SCS CLARIS SPINAL SYSTEM,EXTENDED OMNIAXIALO (K021919) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K021919 · Ortho Tec, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
22d
Days
Class 2
Risk

K021919 is an FDA 510(k) clearance for the SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDIUM, MODEL CO05, S.... Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Ortho Tec, LLC (Chesterland, US). The FDA issued a Cleared decision on July 3, 2002 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 Ortho Tec, LLC devices

Submission Details

510(k) Number K021919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2002
Decision Date July 03, 2002
Days to Decision 22 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
100d faster than avg
Panel avg: 122d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 99
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K021919.
SYNTHES CERVIFIX/ AXON
K023675 · Synthes (Usa) · Nov 2002
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K021061 · Medtronic Sofamor Danek · Jul 2002
TSRH SPINAL SYSTEM
K021170 · Medtronic Sofamor Danek USA, Inc. · Jul 2002
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K020709 · Medtronic Sofamor Danek · May 2002
SPIRAL RADIUS 90-D RODDING SYSTEM
K020134 · United States Surgical, A Division of Tyco Healthc · Apr 2002
DYNA-LOK CLASSIC SPINAL SYSTEM
K020155 · Medtronic Sofamor Danek · Feb 2002