Cleared Traditional

K191489 - Genesys Spine 3DP Cervical Interbody Sy...

K191489 is the FDA 510(k) clearance for Genesys Spine 3DP Cervical Interbody Sy... by Genesys Spine. It is a Class 2 Orthopedic device (product code OVE) cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K191489 · Genesys Spine · Orthopedic device
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Jan 2020
Decision
218d
Days
Class 2
Risk

K191489 is an FDA 510(k) clearance for the Genesys Spine 3DP Cervical Interbody System. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Genesys Spine (Austin, US). The FDA issued a Cleared decision on January 8, 2020 after a review of 218 days - an extended review cycle.

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 Genesys Spine devices

Submission Details

510(k) Number K191489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2019
Decision Date January 08, 2020
Days to Decision 218 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
96d slower than avg
Panel avg: 122d · This submission: 218d
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 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 K191489.
NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System
K200543 · Nexxt Spine, LLC · Mar 2020
Mecta-C Stand Alone
K192906 · Medacta International S.A. · Mar 2020
Atlas Spine Expandable Cervical Standalone Interbody System
K192570 · Atlas Spine, Inc. · Feb 2020
AEON-C Stand Alone System
K191477 · Huvexel Co. , Ltd. · Nov 2019
NuVasive CoRoent Small Interlock System
K192582 · Nu Vasive, Incorporated · Nov 2019
Cervical Spinal Truss System-Stand Alone (CSTS-SA)
K190870 · 4Web, Inc. · Aug 2019