Cleared Traditional

K153525 - Seneka II Polyscrew Pedicle Fixation System

K153525 is an FDA 510(k) clearance for Seneka II Polyscrew Pedicle Fixation System, manufactured by Senecka Spine. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K153525 · Senecka Spine · Orthopedic device
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Jan 2016
Decision
50d
Days
Class 2
Risk

K153525 is an FDA 510(k) clearance for the Seneka II Polyscrew Pedicle Fixation System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Senecka Spine (Johnson City, US). The FDA issued a Cleared decision on January 28, 2016 after a review of 50 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Senecka Spine devices

FDA 510(k) Submission Details - K153525

510(k) Number K153525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2015
Decision Date January 28, 2016
Days to Decision 50 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
72d faster than avg
Panel avg: 122d · This submission: 50d
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 K153525.
CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION and IPC POWEREASE Systems
K153442 · Medtronic Sofamor Danek USA, Inc. · Feb 2016
CD HORIZON Spinal System
K153589 · Medtronic Sofamor Danek USA, Inc. · Feb 2016
Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System
K153428 · Orthofix, Inc. · Jan 2016
M.U.S.T. Pedicle Screw System
K153664 · Medacta International · Jan 2016
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