Cleared Special

EVOL® ha – Hyper C Cervical Interbody Fusion System (K250605) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K250605 · Cutting Edge Spine, LLC · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 2025
Decision
12d
Days
Class 2
Risk

K250605 is an FDA 510(k) clearance for the EVOL® ha – Hyper C Cervical Interbody Fusion System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Cutting Edge Spine, LLC (Mineral Springs, US). The FDA issued a Cleared decision on March 12, 2025 after a review of 12 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 Cutting Edge Spine, LLC devices

Submission Details

510(k) Number K250605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2025
Decision Date March 12, 2025
Days to Decision 12 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
110d faster than avg
Panel avg: 122d · This submission: 12d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code ODP Intervertebral Fusion Device With Bone Graft, 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.
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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 182
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K250605.
DeGen Medical Latitude-C AM Cervical Interbody Fusion System
K252737 · Degen Medical · Oct 2025
IVA & AEON Cervical and Lumbar Cage System
K250335 · K&J Consulting · Aug 2025
IdentiTi II Cervical Interbody System
K251080 · Alphatec Spine, Inc. · Jul 2025
FIX-C 3D Ti ACIF System
K243915 · Jeil Medical Corporation · Feb 2025
Xenco Medical CancelleX Cervical Interbody System
K243673 · Xenco Medical, LLC · Jan 2025
aprevo® Cervical ACDF
K242260 · Carlsmed, Inc. · Nov 2024