Cleared Traditional

K123549 - POLARIS SPINAL SYSTEM - BALLISTA II PER...

K123549 is an FDA 510(k) clearance for POLARIS SPINAL SYSTEM - BALLISTA II PER..., manufactured by Biomet Spine (Aka Ebi, LLC). The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K123549 · Biomet Spine (Aka Ebi, LLC) · Orthopedic device
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Optimized for regulatory review, auditing and printing
Feb 2013
Decision
98d
Days
Class 2
Risk

K123549 is an FDA 510(k) clearance for the POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT 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 February 25, 2013 after a review of 98 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 Biomet Spine (Aka Ebi, LLC) devices

FDA 510(k) Submission Details - K123549

510(k) Number K123549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2012
Decision Date February 25, 2013
Days to Decision 98 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 122d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 731
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K123549.
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UCENTUM
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CD HORIZON SPINAL SYSTEM
K123809 · Medtronic Sofamor Danek USA, Inc. · Feb 2013
ILLICO MIS POSTERIOR FIXATION SYSTEM
K123623 · Alphatec Spine, Inc. · Feb 2013
MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM
K122571 · Seaspine, Inc. · Dec 2012