Cleared Traditional

Hexanium® ACIF (K193000) - FDA 510(k) Clearance

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

K193000 · Spinevision, S.A.S. · Orthopedic device
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Oct 2020
Decision
358d
Days
Class 2
Risk

K193000 is an FDA 510(k) clearance for the Hexanium® ACIF. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Spinevision, S.A.S. (Antony, FR). The FDA issued a Cleared decision on October 20, 2020 after a review of 358 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Spinevision, S.A.S. devices

Submission Details

510(k) Number K193000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2019
Decision Date October 20, 2020
Days to Decision 358 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
236d slower than avg
Panel avg: 122d · This submission: 358d
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

Lince Consulting, LLC
Sevrina Ciucci

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 93
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K193000.
IdentiTi Cervical Standalone Interbody System
K202812 · Alphatec Spine, Inc. · Dec 2020
Mecta-C Stand Alone Extension
K203076 · Medacta International S.A. · Nov 2020
DOLOMITE Anterior Cervical Stabilization System
K202065 · Astura Medical, LLC · Oct 2020
Cavetto-SA Cervical Cage System
K200115 · Neurostructures, Inc. · Sep 2020
Seaspine WaveForm C Interbody System
K201073 · SeaSpine Orthopedics Corporation · Sep 2020
Shoreline ACS (Anterior Cervical System)
K201646 · SeaSpine Orthopedics Corporation · Sep 2020