Cleared Special

K091067 - 5.5 POLARIS SPINAL SYSTEM

K091067 is an FDA 510(k) clearance for 5.5 POLARIS SPINAL SYSTEM, manufactured by Biomet Spine. The device is a Class 2 Orthopedic device with product code NKB cleared through the Special 510(k) pathway after a 91-day FDA review.

K091067 · Biomet Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
91d
Days
Class 2
Risk

K091067 is an FDA 510(k) clearance for the 5.5 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 Biomet Spine (Parsippany, US). The FDA issued a Cleared decision on July 14, 2009 after a review of 91 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 Biomet Spine devices

FDA 510(k) Submission Details - K091067

510(k) Number K091067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2009
Decision Date July 14, 2009
Days to Decision 91 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
31d faster than avg
Panel avg: 122d · This submission: 91d
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 724
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K091067.
CONQUEST SPINAL SYSTEM
K090320 · Life Spine · Jul 2009
NUVASIVE SPHERX II SYSTEM
K091502 · Nuvasive, Inc. · Jul 2009
CD HORIZON SPINAL SYSTEM
K091442 · Medtronic Sofamor Danek · Jul 2009
MILI (MINIMALLY INVASIVE LUMBAR IMPLANT) SYSTEM
K083004 · Aesculap Implant Systems, Inc. · Jul 2009
MODIFICATION TO: NUVASIVE SPHERX SYSTEM
K090981 · Nuvasive, Inc. · Jul 2009
POLARIS SPINAL SYSTEM
K090523 · Ebi, L.P. · Jul 2009