Cleared Traditional

Advantage-C™ Ti3D Cervical Interbody Fusion Device (K252711) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252711 · Intelivation Technologies · Orthopedic device
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Jan 2026
Decision
134d
Days
Class 2
Risk

K252711 is an FDA 510(k) clearance for the Advantage-C™ Ti3D Cervical Interbody Fusion Device. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Intelivation Technologies (Plymouth Meeting, US). The FDA issued a Cleared decision on January 8, 2026 after a review of 134 days - within the typical 510(k) review window.

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 Intelivation Technologies devices

Submission Details

510(k) Number K252711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2025
Decision Date January 08, 2026
Days to Decision 134 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
12d slower than avg
Panel avg: 122d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K252711.
Curiteva Porous PEEK Cervical Interbody System
K252205 · Curiteva, Inc. · Jan 2026
Curiteva Porous PEEK Cervical Interbody Fusion System
K254061 · Curiteva, Inc. · Jan 2026
Cervical Interbody and VBR Fusion System
K252219 · Sync Surgical · Jan 2026
aprevo® cervical interbody system
K252894 · Carlsmed, Inc. · Jan 2026
MSFX MIKRON PEEK CAGES
K252781 · Mikron Makina Sanayi VE Tic. Ltd. Sti. · Dec 2025
SpineLinc Anterior Cervical Implant System
K250764 · Lincotek Medical · Dec 2025