Cleared Special

K031452 - ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03

K031452 is an FDA 510(k) clearance for ORIA SPINAL CLIP SYSTEM, manufactured by Ortho Tec, LLC. The device is a Class 2 Orthopedic device with product code KWP cleared through the Special 510(k) pathway after a 42-day FDA review.

K031452 · Ortho Tec, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
42d
Days
Class 2
Risk

K031452 is an FDA 510(k) clearance for the ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Ortho Tec, LLC (California, US). The FDA issued a Cleared decision on June 18, 2003 after a review of 42 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.

FDA 510(k) Submission Details - K031452

510(k) Number K031452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2003
Decision Date June 18, 2003
Days to Decision 42 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
80d faster than avg
Panel avg: 122d · This submission: 42d
Pathway characteristics
Modification to existing cleared device.

KWP Device Classification - Class 2, Special Controls

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 415
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K031452.
XIA SPINAL SYSTEM AND XIA STAINLESS STEEL SYSTEM
K031893 · Howmedica Osteonics Corp. · Jul 2003
MODIFICATION TO COLORADO 2 SPINAL SYSTEM
K030875 · Medtronic Sofamor Danek, Inc. · Jun 2003
U & I AMERICA SPINAL HOOK SYSTEM
K031595 · U&I Corp., America · Jun 2003
VANTAGE ANTERIOR FIXATION SYSTEM
K031533 · Medtronic Sofamor Danek, Inc. · Jun 2003
BLACKSTONE POSTERIOR CERVICAL SYSTEM
K030197 · Blackstone Medical, Inc. · Jun 2003
MSD CABLE REDUCTION SYSTEM
K030816 · Medtronic Sofamor Danek · Jun 2003
K031452 · ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03
Download PDF FDA Summary Ortho Tec, LLC