Cleared Traditional

CancelleX Porous Titanium Lumbar Interbody Device (K190364) - FDA 510(k) Clearance

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

K190364 · Xenco Medical, LLC · Orthopedic device
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Optimized for regulatory review, auditing and printing
Apr 2019
Decision
62d
Days
Class 2
Risk

K190364 is an FDA 510(k) clearance for the CancelleX Porous Titanium Lumbar Interbody Device. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Xenco Medical, LLC (San Diego, US). The FDA issued a Cleared decision on April 18, 2019 after a review of 62 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 K190364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2019
Decision Date April 18, 2019
Days to Decision 62 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
60d faster than avg
Panel avg: 122d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize 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

KARA & Associates
Korina A. Akhondzadeh

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 - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 464
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K190364.
UNiD Patient specific 3D printed TLIF cage
K190092 · Medicrea International SA · May 2019
Capstone Control™ Spinal System
K190165 · Medtronic Sofamor Danek USA, Inc. · May 2019
HALF DOME Posterior Lumbar Interbody System
K182877 · Astura Medical, LLC · May 2019
CONCORDE LIFT
K182349 · Medos International SARL · Apr 2019
FlareHawk Interbody Fusion System
K183184 · Integrity Implants, Inc. · Apr 2019
MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar Interbody Fusion (PLIF)
K182920 · MiRus, LLC · Mar 2019