Cleared Traditional

K123373 - NAUTILUS SPINAL SYSTEM

K123373 is the FDA 510(k) clearance for NAUTILUS SPINAL SYSTEM by Life Spine. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K123373 · Life Spine · Orthopedic device
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Mar 2013
Decision
125d
Days
Class 2
Risk

K123373 is an FDA 510(k) clearance for the NAUTILUS SPINAL SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Life Spine (Hoffman Est, US). The FDA issued a Cleared decision on March 6, 2013 after a review of 125 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 Life Spine devices

Submission Details

510(k) Number K123373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2012
Decision Date March 06, 2013
Days to Decision 125 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
3d slower than avg
Panel avg: 122d · This submission: 125d
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 649
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K123373.
EXPEDIUM SPINE SYSTEM
K130877 · Medos International SARL · Jun 2013
SOLANAS POSTERIOR STABILIZATION SYSTEM
K131119 · Alphatec Spine, Inc. · May 2013
CD HORIZON SPINAL SYSTEM
K130646 · Medtronic Sofamor Danek USA, Inc. · Apr 2013
CD HORIZON SPINAL SYSTEM
K123809 · Medtronic Sofamor Danek USA, Inc. · Feb 2013
ILLICO MIS POSTERIOR FIXATION SYSTEM
K123623 · Alphatec Spine, Inc. · Feb 2013
ES2 SPINAL SYSTEM MODEL 48280XXXX
K122845 · Stryker Spine · Dec 2012