Cleared Special

K100409 - POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEM

K100409 is an FDA 510(k) clearance for POLARIS SPINAL SYSTEM, manufactured by Biomet Spine (Aka Ebi, LLC). The device is a Class 2 Orthopedic device with product code NKB cleared through the Special 510(k) pathway after a 127-day FDA review.

K100409 · Biomet Spine (Aka Ebi, LLC) · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
127d
Days
Class 2
Risk

K100409 is an FDA 510(k) clearance for the POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Biomet Spine (Aka Ebi, LLC) (Parsippany, US). The FDA issued a Cleared decision on June 23, 2010 after a review of 127 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 - K100409

510(k) Number K100409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2010
Decision Date June 23, 2010
Days to Decision 127 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
5d slower than avg
Panel avg: 122d · This submission: 127d
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 K100409.
MODIFICATION TO:RADIUS SPINAL SYSTEM
K101144 · Stryker Spine · 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
MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEM
K101074 · Medtronic Sofamor Danek USA, Inc. · Jun 2010
AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEM
K100623 · Aesculap Implant Systems · Jun 2010