Cleared Traditional

Axis Anterior Cervical Plate System (K231145) - FDA 510(k) Clearance

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

K231145 · Southern Medical (Pty) , Ltd. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jun 2023
Decision
53d
Days
Class 2
Risk

K231145 is an FDA 510(k) clearance for the Axis Anterior Cervical Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Southern Medical (Pty) , Ltd. (Irene, ZA). The FDA issued a Cleared decision on June 13, 2023 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Southern Medical (Pty) , Ltd. devices

Submission Details

510(k) Number K231145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2023
Decision Date June 13, 2023
Days to Decision 53 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 122d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 243
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K231145.
FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System, and Osprey™ Anterior Cervical Plate System
K231460 · K&J Consulting Corp. · Jul 2023
CODA™ Anterior Cervical Plate System
K230993 · Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech · Jun 2023
Zevo Anterior Cervical Plate System
K231090 · Medtronic Sofamor Danek USA, Inc. · Jun 2023
ATEC Lateral Plate System
K230721 · Alphatec Spine, Inc. · May 2023
Omnia Medical Coupler-A™ Anterior Lumbar Plate System
K230424 · Omnia Medical, LLC · Apr 2023
Cervical Plate System
K223753 · Double Medical Technology, Inc. · Mar 2023