Cleared Traditional

Curiteva Porous PEEK Lumbar Interbody Fusion System (K233744) - FDA 510(k) Clearance

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

K233744 · Curiteva, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jan 2024
Decision
57d
Days
Class 2
Risk

K233744 is an FDA 510(k) clearance for the Curiteva Porous PEEK Lumbar Interbody Fusion System. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Curiteva, Inc. (Tanner, US). The FDA issued a Cleared decision on January 18, 2024 after a review of 57 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. 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 Curiteva, Inc. devices

Submission Details

510(k) Number K233744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2023
Decision Date January 18, 2024
Days to Decision 57 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
65d faster than avg
Panel avg: 122d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
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 Consultant

Mcra, LLC
Justin Eggleton

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 450
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K233744.
Tranquil-L Interbody System
K233375 · Nexus Spine, LLC · Mar 2024
“BioGend” Interbody Fusion System 001 Cage
K233075 · Biogend Therapeutics Co., Ltd. · Mar 2024
restor3d TIDAL Lumbar Interbody Fusion System
K234087 · Restor3d · Jan 2024
Meridian Interbody System
K233694 · SeaSpine Orthopedics Corporation · Jan 2024
Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System, KEYSTONE Cage System
K230872 · Shanghai Sanyou Medical Co, Ltd. · Dec 2023
F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System
K231743 · Corelink, LLC · Dec 2023