Cleared Traditional

K232318 - VICTORY Lumbar Plate System

K232318 is the FDA 510(k) clearance for VICTORY Lumbar Plate System by Globus Medical, Inc.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K232318 · Globus Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2023
Decision
89d
Days
Class 2
Risk

K232318 is an FDA 510(k) clearance for the VICTORY™ Lumbar Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on October 31, 2023 after a review of 89 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 Globus Medical, Inc. devices

Submission Details

510(k) Number K232318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2023
Decision Date October 31, 2023
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
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 421
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K232318.
Segmental Plating System (SPS)
K233640 · Alphatec Spine, Inc. · Feb 2024
MONDRIAN™ Anterior Lumbar Plate System
K231715 · Ctl Medical Corporation · Jan 2024
ADIRA™ Lateral Plate System
K233735 · Globus Medical, Inc. · Jan 2024
Skyway Anterior Cervical Plate System
K231766 · Kyocera Medical Technologies Inc. (KMTI) · Sep 2023
Sapphire X3 Anterior Cervical Plate System
K231593 · Spinal Elements, Inc. · Aug 2023
CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System
K231839 · L & K Biomed Co., Ltd. · Jul 2023