Cleared Special

K212967 - AxTiHA Stand-Alone ALIF System

K212967 is the FDA 510(k) clearance for AxTiHA Stand-Alone ALIF System by Innovasis, Inc.. It is a Class 2 Orthopedic device (product code OVD) cleared through the Special 510(k) pathway after a 29-day FDA review.

K212967 · Innovasis, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2021
Decision
29d
Days
Class 2
Risk

K212967 is an FDA 510(k) clearance for the AxTiHA 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 October 15, 2021 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Innovasis, Inc. devices

Submission Details

510(k) Number K212967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2021
Decision Date October 15, 2021
Days to Decision 29 days
Submission Type Special
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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 K212967.
EL CAPITAN Anterior Lumbar Interbody Fusion System
K214047 · Astura Medical · Mar 2022
Stable-L Standalone Lumbar Interbody System
K212498 · Nexus Spine, LLC · Mar 2022
Tesera-k ALIF System
K212980 · Kyocera Medical Technologies, Inc. · Jan 2022
Axis Spine Technologies ALIF
K210590 · Axis Spine Technologies, Ltd. · Sep 2021
OneLIF Intervertebral Body Replacement System
K211769 · Novapproach Spine · Sep 2021
A-Link Z
K201671 · Acuity Surgical Devices, LLC · May 2021