Cleared Traditional

Axis Spine Technologies ALIF (K210590) - FDA 510(k) Clearance

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

K210590 · Axis Spine Technologies, Ltd. · Orthopedic device
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Sep 2021
Decision
212d
Days
Class 2
Risk

K210590 is an FDA 510(k) clearance for the Axis Spine Technologies ALIF. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Axis Spine Technologies, Ltd. (St. Albans, GB). The FDA issued a Cleared decision on September 29, 2021 after a review of 212 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 Axis Spine Technologies, Ltd. devices

Submission Details

510(k) Number K210590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2021
Decision Date September 29, 2021
Days to Decision 212 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
90d slower than avg
Panel avg: 122d · This submission: 212d
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 115
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K210590.
Stable-L Standalone Lumbar Interbody System
K212498 · Nexus Spine, LLC · Mar 2022
Tesera-k ALIF System
K212980 · Kyocera Medical Technologies, Inc. · Jan 2022
AxTiHA Stand-Alone ALIF System
K212967 · Innovasis, Inc. · Oct 2021
OneLIF Intervertebral Body Replacement System
K211769 · Novapproach Spine · Sep 2021
A-Link Z
K201671 · Acuity Surgical Devices, LLC · May 2021
IdentiTi ALIF Standalone Interbody System
K203742 · Alphatec Spine, Inc. · Apr 2021