Cleared Traditional

K090523 - POLARIS SPINAL SYSTEM

K090523 is the FDA 510(k) clearance for POLARIS SPINAL SYSTEM by Ebi, L.P.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K090523 · Ebi, L.P. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
125d
Days
Class 2
Risk

K090523 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 July 1, 2009 after a review of 125 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Ebi, L.P. devices

Submission Details

510(k) Number K090523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2009
Decision Date July 01, 2009
Days to Decision 125 days
Submission Type Traditional
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
3d slower than avg
Panel avg: 122d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K090523.
NUVASIVE SPHERX II SYSTEM
K091502 · Nuvasive, Inc. · Jul 2009
CD HORIZON SPINAL SYSTEM
K091442 · Medtronic Sofamor Danek · Jul 2009
MODIFICATION TO: NUVASIVE SPHERX SYSTEM
K090981 · Nuvasive, Inc. · Jul 2009
MERCURY SPINAL SYSTEM
K091587 · Spinal Elements, Inc. · Jul 2009
XIA 3 SPINAL SYSTEM, UNIPLANNER/REDUCTION SCREWS & VITALLIUM ROD
K091291 · Stryker Spine · Jun 2009
VIPER 2 SYSTEM
K090648 · Depuy Spine, Inc. · Jun 2009