Cleared Special

K051286 - ZODIAC SPINAL FIXATION SYSTEM

K051286 is an FDA 510(k) clearance for ZODIAC SPINAL FIXATION SYSTEM, manufactured by Alphatec/Nexmed. The device is a Class 2 Orthopedic device with product code MNH cleared through the Special 510(k) pathway after a 30-day FDA review.

K051286 · Alphatec/Nexmed · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K051286

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

MNH Device Classification - Class 2, Special Controls

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 308
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K051286.
SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM
K051697 · Medical Device Advisory Development Group · Sep 2005
XIA 4.5 SPINAL SYSTEM
K050461 · Stryker Spine · Jul 2005
HYDRALOK SYSTEM
K051216 · Altiva Corp. · Jul 2005
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
K050471 · Solco Biomedical Co., Ltd. · May 2005
THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM
K043578 · Solco Biomedical Co., Ltd. · Mar 2005
STRYKER SPINE TRIO PS
K043180 · Stryker Spine · Mar 2005
K051286 · ZODIAC SPINAL FIXATION SYSTEM
Download PDF FDA Summary Alphatec/Nexmed