Cleared Special

K253876 - HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) (FDA 510(k) Clearance)

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

K253876 · Globus Medical, Inc. · Orthopedic device
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Dec 2025
Decision
18d
Days
Class 2
Risk

K253876 is an FDA 510(k) clearance for the HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer). Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on December 22, 2025 after a review of 18 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 Globus Medical, Inc. devices

Submission Details

510(k) Number K253876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2025
Decision Date December 22, 2025
Days to Decision 18 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
104d faster than avg
Panel avg: 122d · This submission: 18d
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 159
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K253876.
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E3D™-C Interbody System
K260038 · Evolution Spine · Feb 2026
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K253200 · 4Web Medical, Inc. · Dec 2025
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