Cleared Traditional

K160216 - Revolution Spinal Fixation System

K160216 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 84-day FDA review.

K160216 · Intelligent Implant Systems, LLC · Orthopedic device
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Apr 2016
Decision
84d
Days
Class 2
Risk

K160216 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 April 22, 2016 after a review of 84 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 Intelligent Implant Systems, LLC devices

FDA 510(k) Submission Details - K160216

510(k) Number K160216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2016
Decision Date April 22, 2016
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
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 K160216.
Threshold Pedicular Fixation System, Palisade Pedicular Fixation System
K160980 · Spineology, Inc. · May 2016
Inertia Pedicle Screw and Deformity Correxxion System
K153453 · Nexxt Spine, LLC · Apr 2016
PASS LP Spinal System
K153413 · Medicrea International SA · Apr 2016
Diplomat® Spinal System
K151704 · Signus Medizintechnik GmbH · Apr 2016
Response 5.5 Spine System
K160466 · OrthoPediatrics Corp. · Mar 2016
Palisade Pedicular Fixation System
K153323 · Spineology, Inc. · Feb 2016