Cleared Traditional

Cervical Spine Truss System (CSTS) (K231739) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231739 · 4Web Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2023
Decision
103d
Days
Class 2
Risk

K231739 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, Inc. (Frisco, US). The FDA issued a Cleared decision on September 25, 2023 after a review of 103 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K231739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2023
Decision Date September 25, 2023
Days to Decision 103 days
Submission Type Traditional
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
19d faster than avg
Panel avg: 122d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Silver Pine Consulting
Richard Jansen

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

All 91
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K231739.
TotalTi ACDF by SAGICO
K233191 · Spinal Analytics & Geometrical Implant Co, LLC · Nov 2023
RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System
K232348 · MiRus, LLC · Oct 2023
Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System
K231704 · Life Spine, Inc. · Oct 2023
ChoiceSpine Blackhawk Ti Cervical Spacer System
K223869 · Choice Spine, LLC · Sep 2023
Stable-C Interbody System
K231763 · Nexus Spine, LLC · Aug 2023
SPICCA Stand-Alone Cervical Fusion Cages
K230608 · Southern Medical (Pty) , Ltd. · Aug 2023