Cleared Special

MODIFICATION TO:RADIUS SPINAL SYSTEM (K101144) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K101144 · Stryker Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
76d
Days
Class 2
Risk

K101144 is an FDA 510(k) clearance for the MODIFICATION TO:RADIUS 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 Stryker Spine (Allendale, US). The FDA issued a Cleared decision on July 8, 2010 after a review of 76 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 Stryker Spine devices

Submission Details

510(k) Number K101144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2010
Decision Date July 08, 2010
Days to Decision 76 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 122d · This submission: 76d
Pathway characteristics
Modification to existing cleared device.

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 403
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K101144.
REVLOK FENESTRATED SCREW SYSTEM
K110280 · Globus Medical, Inc. · Jul 2011
REVERE SACRAL PLATES
K103072 · Globus Medical, Inc. · Mar 2011
CD HORIZON SPINAL SYSTEM
K102555 · Medtronic Sofamor Danek USA, Inc. · Nov 2010
SYNTHES MATRIX SYSTEM
K100634 · Synthes (Usa) · Jul 2010
MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEM
K101074 · Medtronic Sofamor Danek USA, Inc. · Jun 2010
COCR RODS
K100788 · Globus Medical, Inc. · May 2010