Cleared Special

PressON Spinal Fixation System (K233234) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K233234 · Nexus Spine, LLC · Orthopedic device
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Oct 2023
Decision
28d
Days
Class 2
Risk

K233234 is an FDA 510(k) clearance for the PressON 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 October 26, 2023 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nexus Spine, LLC devices

Submission Details

510(k) Number K233234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2023
Decision Date October 26, 2023
Days to Decision 28 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 444
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K233234.
ProMIS Extension Rod System
K232719 · Premia Spine, Ltd. · Nov 2023
MASADA Modular Spinal Fixation System
K231694 · Astura Medical · Nov 2023
ANAX™ 5.5 Spinal System
K231737 · Innosys Co., Ltd. · Oct 2023
PERLA® TL Posterior Thoraco-lumbar Fixation System
K231069 · Spineart SA · Oct 2023
Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System
K232586 · K&J Consulting Corp. · Oct 2023
Ripley Spinal Screw System by SAGICO
K232561 · Sagico VA USA, LLC · Oct 2023