Cleared Traditional

K181677 - Kodiak Spinal Fixation System

K181677 is the FDA 510(k) clearance for Kodiak Spinal Fixation System by Alphatec Spine, Inc.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K181677 · Alphatec Spine, Inc. · Orthopedic device
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Aug 2018
Decision
44d
Days
Class 2
Risk

K181677 is an FDA 510(k) clearance for the Kodiak Spinal Fixation System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Alphatec Spine, Inc. (Carlsnad, US). The FDA issued a Cleared decision on August 9, 2018 after a review of 44 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Alphatec Spine, Inc. devices

Submission Details

510(k) Number K181677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2018
Decision Date August 09, 2018
Days to Decision 44 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
78d faster than avg
Panel avg: 122d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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 - NKB Thoracolumbosacral Pedicle Screw System

All 661
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K181677.
Firebird® Spinal Fixation Systems: Firebird System
K180179 · Orthofix, Inc. · Aug 2018
Zenius™, Iliad™ and Kora™ Spinal Fixation Systems
K181978 · Medyssey USA, Inc. · Aug 2018
Redi-Spine
K181584 · Innovative Surgical Designs, Inc. · Aug 2018
Stowe Pedicle Screw System
K181554 · Black Box Medical · Jul 2018
TREND II Spinal Fixation System- STEP Series
K180226 · Paonan Biotech Co., Ltd. · Jul 2018
Republic Spine Dark Star Spinal System
K181495 · Republic Spine, LLC · Jul 2018