Cleared Special

K023675 - SYNTHES CERVIFIX/ AXON

K023675 is the FDA 510(k) clearance for SYNTHES CERVIFIX/ AXON by Synthes (Usa). It is a Class 2 Orthopedic device (product code KWP) cleared through the Special 510(k) pathway after a 25-day FDA review.

K023675 · Synthes (Usa) · Orthopedic device
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Nov 2002
Decision
25d
Days
Class 2
Risk

K023675 is an FDA 510(k) clearance for the SYNTHES CERVIFIX/ AXON. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on November 26, 2002 after a review of 25 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 Synthes (Usa) devices

Submission Details

510(k) Number K023675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2002
Decision Date November 26, 2002
Days to Decision 25 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
97d faster than avg
Panel avg: 122d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 265
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K023675.
LAURAIN DEWALD ANTERIOR FIXATION SYSTEM
K023797 · Medtronic Sofamor Danek · Dec 2002
CD HORIZON SPINAL SYSTEM
K014296 · Medtronic Sofamor Danek · Dec 2002
INTERPORE CROSS INTERNATIONAL (ICI) OCCIPITO-CERVICO-THORACIC (OCT) ROD AND PLATE SYSTEM
K022048 · Interpore Cross Intl. · Dec 2002
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K023555 · Medtronic Sofamor Danek, Inc. · 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