Cleared Traditional

K163056 - Revolution Spinal Fixation System

K163056 is an FDA 510(k) clearance for Revolution Spinal Fixation System, manufactured by Intelligent Implant Systems, LLC. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K163056 · Intelligent Implant Systems, LLC · Orthopedic device
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Feb 2017
Decision
115d
Days
Class 2
Risk

K163056 is an FDA 510(k) clearance for the Revolution™ Spinal 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 Intelligent Implant Systems, LLC (Charlotte, US). The FDA issued a Cleared decision on February 24, 2017 after a review of 115 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 Intelligent Implant Systems, LLC devices

FDA 510(k) Submission Details - K163056

510(k) Number K163056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2016
Decision Date February 24, 2017
Days to Decision 115 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
7d faster than avg
Panel avg: 122d · This submission: 115d
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 716
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K163056.
USS System
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K163604 · SeaSpine Orthopedics Corporation · Mar 2017
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K170126 · Nu Vasive, Incorporated · Mar 2017
PASS LP Spinal System
K162786 · Medicrea International SA · Jan 2017
CD HORIZON® Spinal System
K163301 · Medtronic Sofamor Danek USA, Inc. · Dec 2016
ENNOVATE Spinal System
K162134 · Aesculap Implant Systems, LLC · Dec 2016