Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

MiRus, LLC — Predicate Candidate Screening

24 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

88 daysmedian FDA review time
277 days90th percentile
24clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K253444EUROPA™ Posterior Cervical Fusion Navigated InstrumentsMiRus, LLC2026-03-181670
K252733ATLAS™ Expandable Osteotomy Wedge SystemMiRus, LLC2026-02-191750
K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC2024-11-19880
K241175MiRus MoRe Lumbar Plating SystemMiRus, LLC2024-05-17210
K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SysMiRus, LLC2023-10-27810
K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC2023-10-13580
K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with IntegrMiRus, LLC2023-09-11530
K230369EUROPA™ Navigated InstrumentsMiRus, LLC2023-06-231330
K220441CYGNUS™ MoRe Anterior Cervical Plate SystemMiRus, LLC2022-09-162120
K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystMiRus, LLC2022-05-131190
K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC2021-08-201570
K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC2020-06-11870
K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting MiRus, LLC2020-05-183070
K191867ATLAS Plating SystemMiRus, LLC2020-04-092720
K192268Europa Pedicle Screw SystemMiRus, LLC2019-10-22620
K191757EUROPA Pedicle Screw SystemMiRus, LLC2019-07-19180
K182524GALILEO Spine Alignment Monitoring SystemMiRus, LLC2019-06-172770
K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC2019-06-06870
K190666CYGNUS™ Anterior Cervical Plate SystemMiRus, LLC2019-05-09550
K190415ATLAS Plating SystemMiRus, LLC2019-04-19570
K180337EUROPA Pedicle Screw SystemMiRus, LLC2019-03-144000
K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTOMiRus, LLC2019-03-131450
K182970EUROPA™ Pedicle Screw SystemMiRus, LLC2019-01-22880
K182989AURORA™ Screw SystemMiRus, LLC2018-12-18500

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda