Cleared Traditional

K071890 - ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SY...

K071890 is the FDA 510(k) clearance for ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SY... by Alphatec Spine, Inc.. It is a Class 2 Orthopedic device (product code MNH) cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K071890 · Alphatec Spine, Inc. · Orthopedic device
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Nov 2007
Decision
123d
Days
Class 2
Risk

K071890 is an FDA 510(k) clearance for the ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Alphatec Spine, Inc. (Carlsbad, US). The FDA issued a Cleared decision on November 9, 2007 after a review of 123 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Alphatec Spine, Inc. devices

Submission Details

510(k) Number K071890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2007
Decision Date November 09, 2007
Days to Decision 123 days
Submission Type Traditional
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
1d slower than avg
Panel avg: 122d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 154
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K071890.
ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS SYSTEM
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MOUNTAINEER OCT SPINAL SYSTEM
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RANGE SPINAL SYSTEM, LARGE DENALI SCREWS
K081381 · K2m, Inc. · Jun 2008
CAPLESS LI PEDICLE SCREW SYSTEM
K072282 · X-Spine Systems, Inc. · Sep 2007
MODIFICATION TO EXPEDIUM SPINE SYSTEM
K062174 · Depuy Spine, Inc. · Nov 2006
ISS INTEGRATED SPINE SYSTEM
K061524 · Ortho Development Corp. · Sep 2006