Cleared Traditional

K232154 - MiRus 3DR Lateral Lumbar Interbody Fusi...

K232154 is the FDA 510(k) clearance for MiRus 3DR Lateral Lumbar Interbody Fusi... by MiRus, LLC. It is a Class 2 Orthopedic device (product code OVD) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K232154 · MiRus, LLC · Orthopedic device
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Sep 2023
Decision
53d
Days
Class 2
Risk

K232154 is an FDA 510(k) clearance for the MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by MiRus, LLC (Marietta, US). The FDA issued a Cleared decision on September 11, 2023 after a review of 53 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 MiRus, LLC devices

Submission Details

510(k) Number K232154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2023
Decision Date September 11, 2023
Days to Decision 53 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
69d faster than avg
Panel avg: 122d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.
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 - OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

All 144
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K232154.
Stable-L Standalone Lumbar Interbody System
K231486 · Nexus Spine, LLC · Oct 2023
IdentiTi ALIF Interbody Systems
K232097 · Alphatec Spine, Inc. · Sep 2023
Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System
K232530 · Nexus Spine, LLC · Sep 2023
NuVasive Modulus ALIF System
K230894 · Nu Vasive, Incorporated · Jun 2023
Zavation ALIF System
K230731 · Zavation Medical Products, LLC · Jun 2023
PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System
K230808 · Kyocera Medical Technologies, Inc. · Apr 2023