510(k) Report

FDA applicant

MiRus, LLC

Marietta, GA24 decisions2018–20260 recalls

FDA records 24 decisions for MiRus, LLC (Marietta, GA) from 2018 to 2026: 24 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and KWQ (Appliance, Fixation, Spinal Intervertebral Body). Since 2016 its 510(k)s took a median of 88 days from receipt to decision, against 91 for FDA’s reviews in the same codes and years. Its devices cite 54 predicates, 14 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided MiRus, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2018: 12019: 92020: 32021: 12022: 22023: 42024: 22026 (partial year): 2
2018high 9 (2019) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — MiRus, LLC by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like MiRus, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • NKBThoracolumbosacral Pedicle Screw System4decisions
  • KWQAppliance, Fixation, Spinal Intervertebral Body3decisions
  • OLOOrthopedic Stereotaxic Instrument3decisions
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar3decisions
  • OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar2decisions
  • HRSPlate, Fixation, Bone2decisions

Also: ODP (2), OVE (1), PLR (1), PLF (1), HWC (1), NKG (1).

How long do its 510(k) reviews take?

Since 2016, its 22 510(k)s took a median of 88 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 91 days; 12 of its 22 were faster than that.

Whose devices does it build on?

Its devices cite 54 predicates; 14 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 20 times; 14 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K180337EUROPA Pedicle Screw SystemMiRus, LLC · 20194cite it
  • K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D…MiRus, LLC · 20203cite it
  • K182970EUROPA™ Pedicle Screw SystemMiRus, LLC · 20192cite it
  • K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar Interbody Fusion (PLIF)…MiRus, LLC · 20192cite it
  • K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC · 20212cite it
  • K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC · 20231cites it

What has FDA decided for it lately?

  • K253444EUROPA™ Posterior Cervical Fusion Navigated InstrumentsMiRus, LLC · 2026
  • K252733ATLAS™ Expandable Osteotomy Wedge SystemMiRus, LLC · 2026
  • K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC · 2024
  • K241175MiRus MoRe Lumbar Plating SystemMiRus, LLC · 2024
  • K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC · 2023
  • K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC · 2023
  • K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC · 2023
  • K230369EUROPA™ Navigated InstrumentsMiRus, LLC · 2023

All 24 as MiRus, LLC →