Cleared Special

K133564 - MODIFICATION TO NAUTILUS SPINAL SYSTEM

K133564 is an FDA 510(k) clearance for MODIFICATION TO NAUTILUS SPINAL SYSTEM, manufactured by Life Spine, LLC. The device is a Class 2 Orthopedic device with product code NKB cleared through the Special 510(k) pathway after a 91-day FDA review.

K133564 · Life Spine, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
91d
Days
Class 2
Risk

K133564 is an FDA 510(k) clearance for the MODIFICATION TO 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, LLC (Hoffman Estates, US). The FDA issued a Cleared decision on February 19, 2014 after a review of 91 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.

FDA 510(k) Submission Details - K133564

510(k) Number K133564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2013
Decision Date February 19, 2014
Days to Decision 91 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
31d faster than avg
Panel avg: 122d · This submission: 91d
Pathway characteristics
Modification to existing cleared device.

NKB Device Classification - Class 2, Special Controls

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 913
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K133564.
ARSENAL SPINAL FIXATION SYSTEM
K133221 · Alphatec Spine, Inc. · Mar 2014
POLARIS SPINAL SYSTEM
K133746 · Biomet Spine (Aka Ebi, LLC) · Mar 2014
REVERE STABILIZATION SYSTEM
K133350 · Globus Medical, Inc. · Mar 2014
SAVANNAH-T, REDUCTION, SAVANNAH-T, HIGH-TOP, SAVANNAH-T, MONOAXIAL MID-TOP, SAVANNAH-T, LOW-TOP, SAVANNAH-LINK
K132925 · Amendia, Inc. · Feb 2014
TIGER SPINE SYSTEM
K133369 · Corelink, LLC · Jan 2014
SANTIS PEDICLE SCREW SYSTEM
K133063 · Lanterna Medical Technologies · Jan 2014