Cleared Traditional

K190959 - ARTiC-L 3D Ti Spinal System with TiONIC...

K190959 is the FDA 510(k) clearance for ARTiC-L 3D Ti Spinal System with TiONIC... by Medtronic Sofamor Danek USA, Inc.. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K190959 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
82d
Days
Class 2
Risk

K190959 is an FDA 510(k) clearance for the ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal Sys.... 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 Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on July 3, 2019 after a review of 82 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 Medtronic Sofamor Danek USA, Inc. devices

Submission Details

510(k) Number K190959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2019
Decision Date July 03, 2019
Days to Decision 82 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
40d faster than avg
Panel avg: 122d · This submission: 82d
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 603
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K190959.
Nexxt Matrixx System
K191408 · Nexxt Spine, LLC · Jul 2019
Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs: Fortilink®-TS IBF System, Fortilink®-L I BF System, Fortilink®-C IBF System
K190498 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Jul 2019
Harrier-SA Lumbar Interbody System
K191367 · Choice Spine, LLC · Jul 2019
TxTi IBF System
K183064 · Innovasis, Inc. · Jun 2019
LxHA PEEK Lateral IBF System
K190684 · Innovasis, Inc. · Jun 2019
ProLift® Expandable System
K191005 · Life Spine, Inc. · Jun 2019