Cleared Traditional

K162236 - Ax Stand-Alone ALIF System

K162236 is the FDA 510(k) clearance for Ax 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 254-day FDA review.

K162236 · Innovasis, Inc. · Orthopedic device
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Apr 2017
Decision
254d
Days
Class 2
Risk

K162236 is an FDA 510(k) clearance for the Ax 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 April 20, 2017 after a review of 254 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 Innovasis, Inc. devices

Submission Details

510(k) Number K162236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2016
Decision Date April 20, 2017
Days to Decision 254 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
132d slower than avg
Panel avg: 122d · This submission: 254d
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 148
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K162236.
IRIX-A Lumbar Integrated Fusion System
K171567 · X-Spine Systems, Inc. · Aug 2017
Rampart One Lumbar Interbody Fusion Device
K163670 · Spineology, Inc. · May 2017
NuVasive BASE Interfixated Titanium System
K170592 · Nu Vasive, Incorporated · Apr 2017
MectaLIF Anterior Stand Alone
K170455 · Medacta International S.A. · Mar 2017
SOVEREIGN® Spinal System
K162680 · Medtronic Sofamor Danek USA, Inc. · Dec 2016
SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device
K162351 · SeaSpine Orthopedics Corporation · Dec 2016