MiRus, LLC: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “MiRus, LLC” (first 2018, latest 2026), across 12 product codes in 1 review panel. Median 510(k) review time under this name: 88 days. Since 2017 the median was 88 days, against 91 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 1 | 50 |
| 2019 | 9 | 87 |
| 2020 | 3 | 272 |
| 2021 | 1 | 157 |
| 2022 | 2 | 166 |
| 2023 | 4 | 70 |
| 2024 | 2 | 54 |
| 2025 | 0 | — |
| 2026 | 2 | 171 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name MiRus, LLC took a median 88 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 91 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 4 | 4 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 3 | 3 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 3 | 3 |
| OLO | Orthopedic Stereotaxic Instrument | 3 | 3 |
| HRS | Plate, Fixation, Bone | 2 | 2 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | 2 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 2 | 2 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| NKG | Posterior Cervical Screw System | 1 | 1 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 | 1 |
Plus 2 more product codes.
Review panels
- Orthopedic (24)
Most recent MiRus, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253444 | EUROPA Posterior Cervical Fusion Navigated Instruments | OLO | 2026-03-18 | 167 |
| K252733 | ATLAS Expandable Osteotomy Wedge System | PLF | 2026-02-19 | 175 |
| K242516 | EUROPA Posterior Cervical Fusion System | NKG | 2024-11-19 | 88 |
| K241175 | MiRus MoRe Lumbar Plating System | KWQ | 2024-05-17 | 21 |
| K232348 | RIGEL 3DR Standalone Anterior Cervical Interbody Fusion System | OVE | 2023-10-27 | 81 |
| K232481 | RIGEL 3DR Anterior Cervical Corpectomy System | PLR | 2023-10-13 | 58 |
| K232154 | MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation | OVD | 2023-09-11 | 53 |
| K230369 | EUROPA Navigated Instruments | OLO | 2023-06-23 | 133 |
| K220441 | CYGNUS MoRe Anterior Cervical Plate System | KWQ | 2022-09-16 | 212 |
| K220115 | ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System | OVD | 2022-05-13 | 119 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named MiRus, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named MiRus, LLC is the lead sponsor of 2 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT07278310: STAR Trial (Siegel Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis) (Recruiting, started 2026-04)
- NCT06680427: Siegel™ Transcatheter Aortic Valve Replacement System (TAVR) Early Feasibility Study (Active not recruiting, started 2025-03-26)
Frequently asked questions
How many FDA 510(k) clearances are listed under MiRus, LLC?
FDA lists 24 510(k) clearances under the applicant name “MiRus, LLC” (first 2018, latest 2026), across 12 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by MiRus, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name MiRus, LLC is 88 days. Since 2017: 88 days, versus 91 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under MiRus, LLC?
The most frequent FDA product codes under this applicant name are NKB (Thoracolumbosacral Pedicle Screw System, 4); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 3); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 3).
Next steps
- See all 24 MiRus, LLC clearances with predicates and recalls
- Run predicate analysis for product code NKB, MiRus, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.