Cleared Traditional

Cervical Spinal Truss System-Stand Alone (CSTS-SA) (K190870) - FDA 510(k) Clearance

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

K190870 · 4Web, Inc. · Orthopedic device
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Aug 2019
Decision
131d
Days
Class 2
Risk

K190870 is an FDA 510(k) clearance for the Cervical Spinal Truss System-Stand Alone (CSTS-SA). Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by 4Web, Inc. (Frisco, US). The FDA issued a Cleared decision on August 12, 2019 after a review of 131 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, Inc. devices

Submission Details

510(k) Number K190870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2019
Decision Date August 12, 2019
Days to Decision 131 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
9d slower than avg
Panel avg: 122d · This submission: 131d
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, LLC
Rich 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 K190870.
Genesys Spine 3DP Cervical Interbody System
K191489 · Genesys Spine · Jan 2020
AEON-C Stand Alone System
K191477 · Huvexel Co. , Ltd. · Nov 2019
NuVasive CoRoent Small Interlock System
K192582 · Nu Vasive, Incorporated · Nov 2019
Elevation Spine Saber-C System
K190885 · Elevation Spine · Aug 2019
Endoskeleton TCS Interbody Fusion Device
K191565 · Titan Spine, Inc. · Aug 2019
NEXXT MATRIXX Stand Alone Cervical System
K190546 · Nexxt Spine, LLC · May 2019