Cleared Traditional

K233735 - ADIRA Lateral Plate System

K233735 is the FDA 510(k) clearance for ADIRA Lateral 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 64-day FDA review.

K233735 · Globus Medical, Inc. · Orthopedic device
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Jan 2024
Decision
64d
Days
Class 2
Risk

K233735 is an FDA 510(k) clearance for the ADIRA™ Lateral 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 January 25, 2024 after a review of 64 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 K233735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2023
Decision Date January 25, 2024
Days to Decision 64 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
58d faster than avg
Panel avg: 122d · This submission: 64d
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 K233735.
Curiteva Thoracolumbar Plate System
K233360 · Curiteva, Inc. · Feb 2024
Segmental Plating System (SPS)
K233640 · Alphatec Spine, Inc. · Feb 2024
MONDRIAN™ Anterior Lumbar Plate System
K231715 · Ctl Medical Corporation · Jan 2024
VICTORY™ Lumbar Plate System
K232318 · Globus Medical, Inc. · Oct 2023
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