Cleared Special

PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System (K230808) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K230808 · Kyocera Medical Technologies, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Apr 2023
Decision
29d
Days
Class 2
Risk

K230808 is an FDA 510(k) clearance for the PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Kyocera Medical Technologies, Inc. (Redlands, US). The FDA issued a Cleared decision on April 21, 2023 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 Kyocera Medical Technologies, Inc. devices

Submission Details

510(k) Number K230808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2023
Decision Date April 21, 2023
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
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 115
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K230808.
MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation
K232154 · MiRus, LLC · Sep 2023
NuVasive Modulus ALIF System
K230894 · Nu Vasive, Incorporated · Jun 2023
Zavation ALIF System
K230731 · Zavation Medical Products, LLC · Jun 2023
ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)
K221324 · Camber Spine Technologies · Mar 2023
Pisces™-SA STANDALONE ALIF Interbody System
K223413 · Osseus Fusion Systems · Feb 2023
EVOLUTION SPINE Interbody System
K223146 · Evolution Spine · Feb 2023