Cleared Traditional

Axis Spine Technologies ALIF (K200352) - FDA 510(k) Clearance

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

K200352 · Axis Spine Technologies, Ltd. · Orthopedic device
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May 2020
Decision
97d
Days
Class 2
Risk

K200352 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 May 20, 2020 after a review of 97 days - within the typical 510(k) review window.

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 K200352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2020
Decision Date May 20, 2020
Days to Decision 97 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
25d faster than avg
Panel avg: 122d · This submission: 97d
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 K200352.
Monterey AL Interbody System
K201585 · Stryker Corporation · Aug 2020
CORBEL Spacers
K201087 · Globus Medical, Inc. · Jul 2020
Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device
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Hive™ Stand-alone Anterior Lumbar Interbody System
K200541 · Hd Lifesciences, LLC · Apr 2020
EL CAPITAN Anterior Lumber Interbody System
K192492 · Astura Medical, LLC · Apr 2020
ProLift Lateral Fixated
K200338 · Life Spine, Inc. · Apr 2020