Cleared Special

POLARIS SPINAL SYSTEM (K100220) - FDA 510(k) Clearance

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

K100220 · Ebi, L.P. · Orthopedic device
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May 2010
Decision
111d
Days
Class 2
Risk

K100220 is an FDA 510(k) clearance for the POLARIS 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 Ebi, L.P. (Parsippany, US). The FDA issued a Cleared decision on May 17, 2010 after a review of 111 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.

View all Ebi, L.P. devices

Submission Details

510(k) Number K100220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2010
Decision Date May 17, 2010
Days to Decision 111 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
11d faster than avg
Panel avg: 122d · This submission: 111d
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 K100220.
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
SYNTHES MATRIX MIS RODS
K093668 · Synthes (Usa) · Mar 2010
REVERE STABILIZATION SYSTEM
K093294 · Globus Medical, Inc. · Feb 2010