Cleared Traditional

K142531 - F1-Modular Pedicle Screw System

K142531 is an FDA 510(k) clearance for F1-Modular Pedicle Screw System, manufactured by Degen Medical. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K142531 · Degen Medical · Orthopedic device
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Mar 2015
Decision
192d
Days
Class 2
Risk

K142531 is an FDA 510(k) clearance for the F1-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 March 20, 2015 after a review of 192 days - an extended review 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: 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 Degen Medical devices

FDA 510(k) Submission Details - K142531

510(k) Number K142531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2014
Decision Date March 20, 2015
Days to Decision 192 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
70d slower than avg
Panel avg: 122d · This submission: 192d
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 707
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K142531.
VENUS Spinal Fixation System
K143363 · L & K Biomed Co., Ltd. · Apr 2015
CD HORIZON Spinal System, IPC POWEREASE System
K143019 · Medtronic Sofamor Danek USA, Inc. · Apr 2015
Range/Denali/Mesa Spinal System
K150325 · K2m, Inc. · Mar 2015
Nautilus Spinal System
K150390 · Life Spine, Inc. · Mar 2015
CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments
K143375 · Medtronic Sofamor Danek USA, Inc. · Feb 2015
NAUTILUS SPINAL SYSTEM AND SOLSTICE OCT SYSTEM
K141222 · Life Spine, Inc. · Feb 2015