Cleared Special

Cervical Spine Truss System (CSTS) (K251117) - FDA 510(k) Clearance

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

K251117 · 4Web Medical · Orthopedic device
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Optimized for regulatory review, auditing and printing
Apr 2025
Decision
14d
Days
Class 2
Risk

K251117 is an FDA 510(k) clearance for the Cervical Spine Truss System (CSTS). Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by 4Web Medical (Frisco, US). The FDA issued a Cleared decision on April 25, 2025 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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 4Web Medical devices

Submission Details

510(k) Number K251117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2025
Decision Date April 25, 2025
Days to Decision 14 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 122d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.
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 - OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

All 93
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K251117.
SABER-C System
K250540 · Elevation Spine · Aug 2025
Stabilis SA Cervical Stand-Alone System (Various PNs)
K251735 · Acuity Surgical Devices, LLC · Jul 2025
FIX-C PEEK ACIF SA System
K251431 · Jeil Medical Corporation · Jun 2025
Tesera-k SC System
K242928 · Kyocera Medical Technologies, Inc. · Apr 2025
CYLOX® ST
K243188 · Signus Medizintechnik GmbH · Feb 2025
Genesys Spine AIS-C II Cervical Interbody Fusion System
K242483 · Genesys Spine · Feb 2025