Cleared Special

K233594 - Genesys Spine 3DP AIS-C II Cervical Int...

K233594 is the FDA 510(k) clearance for Genesys Spine 3DP AIS-C II Cervical Int... by Genesys Spine. It is a Class 2 Orthopedic device (product code OVE) cleared through the Special 510(k) pathway after a 35-day FDA review.

K233594 · Genesys Spine · Orthopedic device
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Dec 2023
Decision
35d
Days
Class 2
Risk

K233594 is an FDA 510(k) clearance for the Genesys Spine 3DP AIS-C II 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 December 13, 2023 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Genesys Spine devices

Submission Details

510(k) Number K233594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2023
Decision Date December 13, 2023
Days to Decision 35 days
Submission Type Special
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
87d faster than avg
Panel avg: 122d · This submission: 35d
Pathway characteristics
Modification to existing cleared device.

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 112
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K233594.
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