Cleared Traditional

K160820 - PressON Pro Spinal Fixation System

K160820 is an FDA 510(k) clearance for PressON Pro Spinal Fixation System, manufactured by Nexus Spine, LLC. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K160820 · Nexus Spine, LLC · Orthopedic device
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Jun 2016
Decision
96d
Days
Class 2
Risk

K160820 is an FDA 510(k) clearance for the PressON Pro 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 Nexus Spine, LLC (Salt Lake City, US). The FDA issued a Cleared decision on June 28, 2016 after a review of 96 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 Nexus Spine, LLC devices

FDA 510(k) Submission Details - K160820

510(k) Number K160820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2016
Decision Date June 28, 2016
Days to Decision 96 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
26d faster than avg
Panel avg: 122d · This submission: 96d
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 K160820.
PASS LP Spinal System
K161627 · Medicrea International SA · Jul 2016
Threshold™ Pedicular Fixation System
K161694 · Spineology, Inc. · Jul 2016
Expedium Spine System, VIPER and VIPER 2 Systems
K160904 · Medos International SARL · Jul 2016
Arsenal Spinal Fixation System
K161363 · Alphatec Spine, Inc. · Jun 2016
NuVasive® Reline® System
K160989 · Nu Vasive, Incorporated · Jun 2016
Mariner Pedicle Screw System
K160902 · SeaSpine Orthopedics Corporation · May 2016