Cleared Special

restor3d TIDAL Lumbar Interbody Fusion System (K234087) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K234087 · Restor3d · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2024
Decision
31d
Days
Class 2
Risk

K234087 is an FDA 510(k) clearance for the restor3d TIDAL 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 Restor3d (Durham, US). The FDA issued a Cleared decision on January 22, 2024 after a review of 31 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Restor3d devices

Submission Details

510(k) Number K234087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2023
Decision Date January 22, 2024
Days to Decision 31 days
Submission Type Special
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
91d faster than avg
Panel avg: 122d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

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 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 K234087.
aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal lumbar interbody fusion device
K232282 · Carlsmed, Inc. · Mar 2024
Tranquil-L Interbody System
K233375 · Nexus Spine, LLC · Mar 2024
“BioGend” Interbody Fusion System 001 Cage
K233075 · Biogend Therapeutics Co., Ltd. · Mar 2024
Curiteva Porous PEEK Lumbar Interbody Fusion System
K233744 · Curiteva, Inc. · 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