Cleared Special

K253876 - HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)

K253876 is an FDA 510(k) clearance for HEDRON Cervical Spacers (HEDRON C-MIS S..., manufactured by Globus Medical, Inc.. The device is a Class 2 Orthopedic device with product code OVE cleared through the Special 510(k) pathway after a 18-day FDA review.

K253876 · Globus Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K253876

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.

OVE Device Classification - Class 2, Special Controls

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 168
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K253876.
SAGI Cervical Cage System
K253213 · ZheJiang Decans Medical Devices Co., Ltd. · Apr 2026
Uni-C Cervical Cage System
K252774 · ZheJiang Decans Medical Devices Co., Ltd. · Apr 2026
E3D™-C Interbody System
K260038 · Evolution Spine · Feb 2026
Cervical Spine Truss System - Stand Alone (CSTS-SA)
K253200 · 4Web Medical, Inc. · Dec 2025
Endeavor™ Stand-Alone Cervical IBF System
K250076 · Innovasis · Sep 2025
SABER-C System
K250540 · Elevation Spine · Aug 2025
K253876 · HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)
Download PDF FDA Summary Globus Medical, Inc.