Cleared Traditional

K182139 - AXTi Titanium Stand-Alone ALIF System

K182139 is the FDA 510(k) clearance for AXTi Titanium Stand-Alone ALIF System by Innovasis, Inc.. It is a Class 2 Orthopedic device (product code OVD) cleared through the Traditional 510(k) pathway after a 318-day FDA review.

K182139 · Innovasis, Inc. · Orthopedic device
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Jun 2019
Decision
318d
Days
Class 2
Risk

K182139 is an FDA 510(k) clearance for the AXTi Titanium Stand-Alone ALIF System. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Innovasis, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on June 21, 2019 after a review of 318 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Innovasis, Inc. devices

Submission Details

510(k) Number K182139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2018
Decision Date June 21, 2019
Days to Decision 318 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
196d slower than avg
Panel avg: 122d · This submission: 318d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.
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 - OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

All 144
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K182139.
SAHARA Stabilization System
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K192054 · Titan Spine, Inc. · Aug 2019
Rampart™ One Lumbar Interbody Fusion System
K192047 · Spineology, Inc. · Aug 2019
Idys ALIF TiVac
K191263 · Clariance, Sas · Jun 2019
Juliet® Ti LL Lumbar Interbody Device
K190877 · Spineart · May 2019
Rampart One Lumbar Interbody Fusion System
K191091 · Spineology, Inc. · May 2019