Cleared Traditional

CancelleX Porous Titanium Lumbar Interbody Device (K180373) - FDA 510(k) Clearance

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

K180373 · Xenco Medical, LLC · Orthopedic device
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Aug 2018
Decision
193d
Days
Class 2
Risk

K180373 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 August 24, 2018 after a review of 193 days - an extended review 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: 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 Xenco Medical, LLC devices

Submission Details

510(k) Number K180373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2018
Decision Date August 24, 2018
Days to Decision 193 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
71d slower than avg
Panel avg: 122d · This submission: 193d
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 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 K180373.
LnK Lumbar Interbody Fusion Cage System
K181380 · L & K Biomed Co., Ltd. · Sep 2018
Renovis S180 Lateral Lumbar Interbody Fusion System
K181655 · Renovis Surgical Technologies · Sep 2018
Tranquil Interbody System
K181483 · Nexus Spine, LLC · Aug 2018
Aries® Lumbar Interbodies
K181347 · Osseus Fusion Systems, LLC · Aug 2018
Duo™ Lumbar Interbody Fusion Device
K181792 · Spineology, Inc. · Aug 2018
TirboLOX-L Lumbar IBFD
K180990 · Captiva Spine, Inc. · Aug 2018