Cleared Traditional

K182920 - MiRus Lumbar Interbody Fusion System co...

Also marketed or referenced as:
HYPERION™ PEEK Transforaminal Lumbar Interbody Fusion (TLIF) CALPYSO™ PEEK Lateral Lumbar Interbody Fusion (LLIF) ANTARES™ PEEK Anterior Lumbar Interbody Fusion (ALIF)

K182920 is the FDA 510(k) clearance for MiRus Lumbar Interbody Fusion System co... by MiRus, LLC. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K182920 · MiRus, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2019
Decision
145d
Days
Class 2
Risk

K182920 is an FDA 510(k) clearance for the MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior .... 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 March 13, 2019 after a review of 145 days - within the typical 510(k) review window.

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 K182920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2018
Decision Date March 13, 2019
Days to Decision 145 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
23d slower than avg
Panel avg: 122d · This submission: 145d
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 595
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K182920.
CancelleX Porous Titanium Lumbar Interbody Device
K190364 · Xenco Medical, LLC · Apr 2019
CONCORDE LIFT
K182349 · Medos International SARL · Apr 2019
FlareHawk Interbody Fusion System
K183184 · Integrity Implants, Inc. · Apr 2019
Kuros TLIF Cage
K183092 · Kuros Biosciences B.V · Mar 2019
Spectrum Spine Expandable Cages (SSEC)
K173518 · Spectrum Spine, LLC · Mar 2019
Duo Lumbar Interbody Fusion Device
K190055 · Spineology, Inc. · Mar 2019