Cleared Special

K042673 - ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM

K042673 is an FDA 510(k) clearance for ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM, manufactured by Alphatec/Nexmed. The device is a Class 2 Orthopedic device with product code KWP cleared through the Special 510(k) pathway after a 28-day FDA review.

K042673 · Alphatec/Nexmed · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
28d
Days
Class 2
Risk

K042673 is an FDA 510(k) clearance for the ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Alphatec/Nexmed (Carlsbad, US). The FDA issued a Cleared decision on October 27, 2004 after a review of 28 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.

FDA 510(k) Submission Details - K042673

510(k) Number K042673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2004
Decision Date October 27, 2004
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
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 425
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K042673.
VERTEX RECONSTRUCTION SYSTEM
K042789 · Medtronic Sofamor Danek · Dec 2004
MODIFICATION TO ALTIUS OCT SYSTEM
K043229 · Interpore Cross Intl. · Dec 2004
SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.X
K043355 · Sintea Biotech, Inc. · Dec 2004
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K042524 · Medtronic Sofamor Danek · Oct 2004
EXCELLA-M SPINAL SYSTEM
K042143 · Innovasis, Inc. · Oct 2004
VERTEX RECONSTRUCTION SYSTEM
K042498 · Medtronic Sofamor Danek · Oct 2004
K042673 · ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
Download PDF FDA Summary Alphatec/Nexmed