Cleared Traditional

F1 MPS Modular Pedicle Screw System (K160926) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K160926 · Degen Medical · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
85d
Days
Class 2
Risk

K160926 is an FDA 510(k) clearance for the F1 MPS Modular Pedicle Screw System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Degen Medical (Florence, US). The FDA issued a Cleared decision on June 28, 2016 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.

View all Degen Medical devices

Submission Details

510(k) Number K160926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2016
Decision Date June 28, 2016
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 445
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K160926.
M.U.S.T. Pedicle Screw System
K162061 · Medacta International S.A. · Oct 2016
CD HORIZON® Spinal System
K162494 · Medtronic Sofamor Danek USA, Inc. · Oct 2016
NuVasive® Reline® System
K161014 · Nu Vasive, Incorporated · Sep 2016
NuVasive® Reline® System
K160989 · Nu Vasive, Incorporated · Jun 2016
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