Cleared Special

K101144 - MODIFICATION TO:RADIUS SPINAL SYSTEM

K101144 is the FDA 510(k) clearance for MODIFICATION TO:RADIUS SPINAL SYSTEM by Stryker Spine. It is a Class 2 Orthopedic device (product code NKB) cleared through the Special 510(k) pathway after a 76-day FDA review.

K101144 · Stryker Spine · Orthopedic device
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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
Combination Product No
PCCP Authorized No
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 668
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K101144.
QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES
K093692 · Pioneer Surgical Technology · Aug 2010
MODIFICATION TO SYNTHES MATRIX SYSTEM
K100952 · Synthes Spine · Aug 2010
FIREBIRD SPINAL FIXATION SYSTEM
K093926 · Blackstone Medical, Inc. · Jul 2010
SYNTHES MATRIX SYSTEM
K100634 · Synthes (Usa) · Jul 2010
TILOCK PEDICLE SCREW SYSTEM
K100757 · Genesys Spine · Jul 2010
POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM
K100438 · Ebi, L.P. · Jun 2010