Cleared Special

ZODIAC SPINAL FIXATION SYSTEM (K051286) - FDA 510(k) Clearance

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

K051286 · Alphatec/Nexmed · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
30d
Days
Class 2
Risk

K051286 is an FDA 510(k) clearance for the ZODIAC SPINAL FIXATION SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Alphatec/Nexmed (Carlsbad, US). The FDA issued a Cleared decision on June 17, 2005 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 Alphatec/Nexmed devices

Submission Details

510(k) Number K051286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2005
Decision Date June 17, 2005
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MNH Orthosis, Spondylolisthesis Spinal Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 39
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K051286.
EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM
K102870 · Exactech, Inc. · Jan 2011
CD HORIZON SPINAL SYSTEM
K061915 · Medtronic Sofamor Danek · Jul 2006
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K043343 · Medtronic Sofamor Danek · Dec 2004
PROTEX STABILIZATION SYSTEM
K040442 · Globus Medical, Inc. · May 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K034056 · Medtronic Sofamor Danek · Apr 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K033322 · Medtronic Sofamor Danek · Dec 2003