Cleared Traditional

K151849 - Seneka I Polyscrew Pedicle Fixation System

K151849 is an FDA 510(k) clearance for Seneka I 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 85-day FDA review.

K151849 · Senecka Spine · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
85d
Days
Class 2
Risk

K151849 is an FDA 510(k) clearance for the Seneka I 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 September 30, 2015 after a review of 85 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.

FDA 510(k) Submission Details - K151849

510(k) Number K151849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2015
Decision Date September 30, 2015
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
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 Consultant

Silver Pine Consulting, LLC
Rich Jansen

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NKB Thoracolumbosacral Pedicle Screw System

All 913
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K151849.
Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle Screw System, Valencia MIS Pedicle Screw System
K151648 · Altus Partners, LLC · Oct 2015
STERISPINE PS
K151921 · Safe Orthopaedics · Oct 2015
STERISPINE PS
K151747 · Safe Orthopaedics · Oct 2015
Everest Spinal System
K151727 · K2m, Inc. · Sep 2015
Xenco Medical Pedicle Screw System
K151733 · Xenco Medical, LLC · Sep 2015
Fortress Pedicular Fixation System
K152148 · Spineology, Inc. · Sep 2015
K151849 · Seneka I Polyscrew Pedicle Fixation System
Download PDF FDA Summary Senecka Spine