Cleared Traditional

K210800 - IO Expandable Lumbar Interbody Fusion S...

K210800 is the FDA 510(k) clearance for IO Expandable Lumbar Interbody Fusion S... by MiRus, LLC. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K210800 · MiRus, LLC · Orthopedic device
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Aug 2021
Decision
157d
Days
Class 2
Risk

K210800 is an FDA 510(k) clearance for the IO Expandable 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 MiRus, LLC (Marietta, US). The FDA issued a Cleared decision on August 20, 2021 after a review of 157 days - an extended review 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: 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 MiRus, LLC devices

Submission Details

510(k) Number K210800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2021
Decision Date August 20, 2021
Days to Decision 157 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
35d slower than avg
Panel avg: 122d · This submission: 157d
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 Peers - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 603
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K210800.
Impulse AM Interbody Fusion System
K210090 · Degen Medical · Aug 2021
KMTI S141 Lumbar Interbody Fusion System
K212070 · Kyocera Medical Technologies, Inc. · Aug 2021
BEE PLIF Cage
K211413 · NGMedical GmbH · Aug 2021
PSX Interbody System
K211873 · Alphatec Spine, Inc. · Aug 2021
Lateral Spine Truss System (LSTS) Interbody Fusion Device
K211388 · 4Web Medical, Inc. · Aug 2021
Pantheon IBFD
K203003 · Pantheon Spinal · Jul 2021