Cleared Special

K023983 - MODIFICATION TO HIGHGATE CURVED ROD SYSTEM

K023983 is an FDA 510(k) clearance for MODIFICATION TO HIGHGATE CURVED ROD SYSTEM, manufactured by Highgate Orthopaedics. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Special 510(k) pathway after a 294-day FDA review.

K023983 · Highgate Orthopaedics · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
294d
Days
Class 2
Risk

K023983 is an FDA 510(k) clearance for the MODIFICATION TO HIGHGATE CURVED ROD SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Highgate Orthopaedics (Cleveland, US). The FDA issued a Cleared decision on September 22, 2003 after a review of 294 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K023983

510(k) Number K023983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2002
Decision Date September 22, 2003
Days to Decision 294 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
172d slower than avg
Panel avg: 122d · This submission: 294d
Pathway characteristics
Modification to existing cleared device.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 667
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K023983.
R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM
K032752 · R&B Surgical Solutions, LLC · Dec 2003
SONOMA ANTERIOR CERVICAL PLATE SYSTEM
K032368 · Seaspine · Oct 2003
CYCLONE ANTERIOR CERVICAL PLATE SYSTEM
K031214 · Encore Medical, L.P. · Sep 2003
HALM ZIELKE INSTRUMENTATION SYSTEM
K024125 · Micomed Ortho GmbH · Sep 2003
SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM
K031855 · Spinal Concepts, Inc. · Sep 2003
CD HORIZON SPINAL SYSTEM
K032265 · Medtronic Sofamor Danek · Aug 2003
K023983 · MODIFICATION TO HIGHGATE CURVED ROD SYSTEM
Download PDF FDA Summary Highgate Orthopaedics