Cleared Special

K121130 - POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS

K121130 is an FDA 510(k) clearance for POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS, 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 63-day FDA review.

K121130 · Biomet Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
63d
Days
Class 2
Risk

K121130 is an FDA 510(k) clearance for the POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS. 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 June 15, 2012 after a review of 63 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 Biomet Spine devices

FDA 510(k) Submission Details - K121130

510(k) Number K121130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2012
Decision Date June 15, 2012
Days to Decision 63 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
59d faster than avg
Panel avg: 122d · This submission: 63d
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 K121130.
PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
K121671 · Zimmer Spine, Inc. · Jul 2012
CD HORIZON SPINAL SYSTEM
K121680 · Medtronic Sofamor Danek USA, Inc. · Jul 2012
XIA 4.5 SPINAL SYSTEM
K121342 · Stryker Corp. · Jun 2012
EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM
K111136 · Depuy Spine, Inc. · Jun 2012
REVERE 4.5 STABILIZATION SYSTEM
K113395 · Globus Medical, Inc. · Jun 2012
STAINLESS STEEL SPINAL SYSTEM
K120829 · Theken Spine, LLC · May 2012