Cleared Traditional

K140010 - FORTRESS PEDICLE SCREW SYSTEM

K140010 is the FDA 510(k) clearance for FORTRESS PEDICLE SCREW SYSTEM by Spineology, Inc.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K140010 · Spineology, Inc. · Orthopedic device
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Apr 2014
Decision
111d
Days
Class 2
Risk

K140010 is an FDA 510(k) clearance for the FORTRESS 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 Spineology, Inc. (Saint Paul, US). The FDA issued a Cleared decision on April 23, 2014 after a review of 111 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 Spineology, Inc. devices

Submission Details

510(k) Number K140010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2014
Decision Date April 23, 2014
Days to Decision 111 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
11d faster than avg
Panel avg: 122d · This submission: 111d
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 668
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K140010.
RANGE/MESA/DENALI SPINAL SYSTEM
K140765 · K2m, Inc. · Jul 2014
RANGE SPINAL SYSTEM
K141147 · K2m, Inc. · Jun 2014
EXCELLA III-D SPINAL DEFORMITY SYSTEM
K140238 · Innovasis, Inc. · May 2014
CD HORIZON SPINAL SYSTEM
K140449 · Medtronic Sofamor Danek, Inc. · Mar 2014
NAUTILUS SPINAL SYSTEM
K140457 · Life Spine, Inc. · Mar 2014
RANGE, SPINAL SYSTEM, EVEREST SPINAL SYSTEM
K133944 · K2m, Inc. · Mar 2014