Cleared Traditional

Xenco Medical CancelleX Cervical Interbody System (K243673) - FDA 510(k) Clearance

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

K243673 · Xenco Medical, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2025
Decision
63d
Days
Class 2
Risk

K243673 is an FDA 510(k) clearance for the Xenco Medical CancelleX Cervical Interbody System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Xenco Medical, LLC (San Diego, US). The FDA issued a Cleared decision on January 29, 2025 after a review of 63 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Xenco Medical, LLC devices

Submission Details

510(k) Number K243673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2024
Decision Date January 29, 2025
Days to Decision 63 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
59d faster than avg
Panel avg: 122d · This submission: 63d
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 Consultant

Watershed Idea Foundry, Inc. (Dba Spitrex 3D)
Jeffrey Brittan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K243673.
IdentiTi II Cervical Interbody System
K251080 · Alphatec Spine, Inc. · Jul 2025
EVOL® ha – Hyper C Cervical Interbody Fusion System
K250605 · Cutting Edge Spine, LLC · Mar 2025
FIX-C 3D Ti ACIF System
K243915 · Jeil Medical Corporation · Feb 2025
aprevo® Cervical ACDF
K242260 · Carlsmed, Inc. · Nov 2024
ZSFab Cervical Interbody System
K242734 · Zsfab · Nov 2024
Gemini Cervical Fusion Cage System
K242195 · ZheJiang Decans Medical Devices Co., Ltd. · Nov 2024