Cleared Special

K100138 - ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM

K100138 is the FDA 510(k) clearance for ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM by Alphatec Spine, Inc.. It is a Class 2 Orthopedic device (product code MNI) cleared through the Special 510(k) pathway after a 29-day FDA review.

K100138 · Alphatec Spine, Inc. · Orthopedic device
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Feb 2010
Decision
29d
Days
Class 2
Risk

K100138 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 February 17, 2010 after a review of 29 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 Spine, Inc. devices

Submission Details

510(k) Number K100138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2010
Decision Date February 17, 2010
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 159
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K100138.
RANGE SPINAL SYSTEM
K100851 · K2m, Inc. · Aug 2010
AEGIS & AEGIS II SPINAL SYSTEM
K092076 · Corentec Co., Ltd. · Apr 2010
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K093936 · Spineart · Mar 2010
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K093077 · Alphatec Spine, Inc. · Dec 2009
CASPIAN SPINAL SYSTEM
K092640 · K2m, Inc. · Nov 2009
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K093170 · Spineart · Nov 2009