Cleared Traditional

K151974 - Polaris Spinal System

K151974 is an FDA 510(k) clearance for Polaris Spinal System, manufactured by Biomet Spine. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K151974 · Biomet Spine · Orthopedic device
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Nov 2015
Decision
120d
Days
Class 2
Risk

K151974 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 Biomet Spine (Broomfield, US). The FDA issued a Cleared decision on November 13, 2015 after a review of 120 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 devices

FDA 510(k) Submission Details - K151974

510(k) Number K151974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2015
Decision Date November 13, 2015
Days to Decision 120 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
2d faster than avg
Panel avg: 122d · This submission: 120d
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 724
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K151974.
Arsenal Spinal Fixation System
K152968 · Alphatec Spine, Inc. · Dec 2015
CD HORIZON Spinal System, IPC POWEREASE System
K153463 · Medtronic Sofamor Danek USA, Inc. · Dec 2015
XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory
K152632 · Stryker Corporation · Dec 2015
CD HORIZON Spinal System
K152248 · Medtronic Sofamor Danek USA, Inc. · Nov 2015
Genesys Spine TiLock2 Spinal System
K152039 · Genesys Spine · Oct 2015
CD HORIZON Spinal System
K152457 · Medtronic Sofamor Danek USA, Inc. · Oct 2015