Cleared Special

K090779 - ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM

K090779 is an FDA 510(k) clearance for ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM, manufactured by Alphatec Spine, Inc.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Special 510(k) pathway after a 106-day FDA review.

K090779 · Alphatec Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Jul 2009
Decision
106d
Days
Class 2
Risk

K090779 is an FDA 510(k) clearance for the ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Alphatec Spine, Inc. (Carlsnad, US). The FDA issued a Cleared decision on July 7, 2009 after a review of 106 days - within the typical 510(k) review window.

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. 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.

View all Alphatec Spine, Inc. devices

FDA 510(k) Submission Details - K090779

510(k) Number K090779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2009
Decision Date July 07, 2009
Days to Decision 106 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
16d faster than avg
Panel avg: 122d · This submission: 106d
Pathway characteristics
Modification to existing cleared device.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle 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 - MNI Orthosis, Spinal Pedicle Fixation

All 266
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K090779.
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K093170 · Spineart · Nov 2009
MODIFICATION TO: PSS SYSTEM
K092128 · Spinal USA · Sep 2009
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K091189 · Alphatec Spine, Inc. · Jul 2009
INERTIA PEDICLE SCREW SYSTEM
K090984 · Nexxt Spine, LLC · Jun 2009
MODIFICATION TO: PSS SYSTEM
K090033 · Spinal USA · May 2009
THEKEN ATOLL OCT SPINAL SYSTEM
K083863 · Theken Spine, LLC · Mar 2009