Cleared Special

STRUXXURE® MCS Anterior Cervical Plate System (K240690) - FDA 510(k) Clearance

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

K240690 · Nexxt Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
9d
Days
Class 2
Risk

K240690 is an FDA 510(k) clearance for the STRUXXURE® MCS Anterior Cervical Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Nexxt Spine (Noblesville, US). The FDA issued a Cleared decision on March 22, 2024 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 Nexxt Spine devices

Submission Details

510(k) Number K240690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2024
Decision Date March 22, 2024
Days to Decision 9 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
113d faster than avg
Panel avg: 122d · This submission: 9d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 244
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K240690.
MSFX Mikron Cervical Anterior Plate System
K240484 · Mikron Makina Sanayi VE Ticaret Ltd. Sti. · Apr 2024
Alcantara Thoracolumbar Plate System
K232256 · Camber Spine Technologies, LLC · Apr 2024
TDM Anterior Cervical Plate System
K240423 · Tdm Co., Ltd. · Apr 2024
uNion® MAX Cervical Plate System
K240515 · Ulrich Medical USA, Inc. · Mar 2024
Curiteva Thoracolumbar Plate System
K233360 · Curiteva, Inc. · Feb 2024
Segmental Plating System (SPS)
K233640 · Alphatec Spine, Inc. · Feb 2024