Cleared Traditional

Curiteva Thoracolumbar Plate System (K233360) - FDA 510(k) Clearance

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

K233360 · Curiteva, Inc. · Orthopedic device
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Feb 2024
Decision
153d
Days
Class 2
Risk

K233360 is an FDA 510(k) clearance for the Curiteva Thoracolumbar Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Curiteva, Inc. (Tanner, US). The FDA issued a Cleared decision on February 29, 2024 after a review of 153 days - an extended review 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: 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 Curiteva, Inc. devices

Submission Details

510(k) Number K233360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2023
Decision Date February 29, 2024
Days to Decision 153 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
31d slower than avg
Panel avg: 122d · This submission: 153d
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 241
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K233360.
TDM Anterior Cervical Plate System
K240423 · Tdm Co., Ltd. · Apr 2024
STRUXXURE® MCS Anterior Cervical Plate System
K240690 · Nexxt Spine · Mar 2024
uNion® MAX Cervical Plate System
K240515 · Ulrich Medical USA, Inc. · Mar 2024
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