Cleared Traditional

K192906 - Mecta-C Stand Alone

K192906 is the FDA 510(k) clearance for Mecta-C Stand Alone by Medacta International S.A.. It is a Class 2 Orthopedic device (product code OVE) cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K192906 · Medacta International S.A. · Orthopedic device
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Mar 2020
Decision
141d
Days
Class 2
Risk

K192906 is an FDA 510(k) clearance for the Mecta-C Stand Alone. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Medacta International S.A. (Castel San Pietro (Ch), CH). The FDA issued a Cleared decision on March 4, 2020 after a review of 141 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 Medacta International S.A. devices

Submission Details

510(k) Number K192906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2019
Decision Date March 04, 2020
Days to Decision 141 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 slower than avg
Panel avg: 122d · This submission: 141d
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

Medacta USA
Chris Lussier

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 114
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K192906.
F3D Cervical Stand-Alone Interbody Fusion System
K200087 · Corelink, LLC · Jun 2020
SPIRA-C Integrated Fixation System
K193153 · Camber Spine Technologies · Apr 2020
NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System
K200543 · Nexxt Spine, LLC · Mar 2020
Atlas Spine Expandable Cervical Standalone Interbody System
K192570 · Atlas Spine, Inc. · Feb 2020
Genesys Spine 3DP Cervical Interbody System
K191489 · Genesys Spine · Jan 2020
AEON-C Stand Alone System
K191477 · Huvexel Co. , Ltd. · Nov 2019