Cleared Special

SPINAL CONCEPTS INC. CADENCE AND TRAXIS (K033517) - FDA 510(k) Clearance

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

K033517 · Spinal Concepts, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
103d
Days
Class 2
Risk

K033517 is an FDA 510(k) clearance for the SPINAL CONCEPTS INC. CADENCE AND TRAXIS. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Spinal Concepts, Inc. (Austin, US). The FDA issued a Cleared decision on February 18, 2004 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Spinal Concepts, Inc. devices

Submission Details

510(k) Number K033517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2003
Decision Date February 18, 2004
Days to Decision 103 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
19d faster than avg
Panel avg: 122d · This submission: 103d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - MQP Spinal Vertebral Body Replacement Device

All 68
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K033517.
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K040536 · Medtronic Sofamor Danek · May 2004
SUSTAIN RADIOLUCENT SPACER
K040284 · Globus Medical, Inc. · Mar 2004
MODIFICATION TO VERTE-STACK
K040422 · Medtronic Sofamor Danek · Mar 2004
VERTE-STACK SPINAL SYSTEM
K040167 · Medtronic Sofamor Danek · Feb 2004
STRYKER SPINE VERTEBRAL BODY SUPPORT SYSTEM
K033837 · Howmedica Osteonics Corp. · Jan 2004
VERTE-STACK SPINAL SYSTEM
K031780 · Medtronic Sofamor Danek · Jul 2003