Cleared Special

K022374 - CADENCE SPINAL FIXATION SYSTEM

K022374 is an FDA 510(k) clearance for CADENCE SPINAL FIXATION SYSTEM, manufactured by Sulzer Spine-Tech. The device is a Class 2 Orthopedic device with product code KWP cleared through the Special 510(k) pathway after a 64-day FDA review.

K022374 · Sulzer Spine-Tech · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
64d
Days
Class 2
Risk

K022374 is an FDA 510(k) clearance for the CADENCE SPINAL FIXATION SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Sulzer Spine-Tech (Minneapolis, US). The FDA issued a Cleared decision on September 24, 2002 after a review of 64 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 Sulzer Spine-Tech devices

FDA 510(k) Submission Details - K022374

510(k) Number K022374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2002
Decision Date September 24, 2002
Days to Decision 64 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
58d faster than avg
Panel avg: 122d · This submission: 64d
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 368
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K022374.
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K023555 · Medtronic Sofamor Danek, Inc. · Nov 2002
ORIA SPINAL CLIP SYSTEM
K021679 · Ortho Tec, LLC · Nov 2002
MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM
K023498 · Blackstone Medical, Inc. · Nov 2002
MODIFICATION TO TENOR SPINAL SYSTEM
K022191 · Medtronic Sofamor Danek, Inc. · Aug 2002
5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM)
K022623 · Depuyacromed · Aug 2002
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K021061 · Medtronic Sofamor Danek · Jul 2002