Cleared Traditional

K021009 - OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEM

K021009 is an FDA 510(k) clearance for OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEM, manufactured by Spinal Concepts, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K021009 · Spinal Concepts, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
82d
Days
Class 2
Risk

K021009 is an FDA 510(k) clearance for the OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Spinal Concepts, Inc. (Austin, US). The FDA issued a Cleared decision on June 18, 2002 after a review of 82 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. 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 Spinal Concepts, Inc. devices

FDA 510(k) Submission Details - K021009

510(k) Number K021009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2002
Decision Date June 18, 2002
Days to Decision 82 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
40d faster than avg
Panel avg: 122d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 309
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K021009.
XANTUS ANTERIOR LATERAL SUPPLEMENTAL FIXATION SYSTEM
K022070 · Medtronic Sofamor Danek, Inc. · Jul 2002
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K022015 · Medtronic Sofamor Danek, Inc. · 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
ENDIUS SPINAL FIXATION SYSTEM
K014090 · Endius, Inc. · Mar 2002