# MiRus, LLC

- Location (FDA's records): Marietta, GA
- FDA decisions: 24 (2018–2026): 24 510(k) clearances
- Product codes: NKB (4), KWQ (3), OLO (3), MAX (3), OVD (2), HRS (2), ODP (2), OVE (1), PLR (1), PLF (1), HWC (1), NKG (1)
- 510(k) review time since 2016: median 88 days, against 91 for FDA's reviews in the same codes and years (12 of 22 faster)
- Predicates its devices cite: 54 (14 its own); citations of its devices by later devices: 20 (14 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Depuy Spine, Inc.: 6 (https://510kreport.com/company/depuy-spine)
- Medtronic Sofamor Danek USA, Inc.: 5 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Orthohelix Surgical Designs, Inc.: 4 (https://510kreport.com/company/orthohelix-surgical-designs)
- Eit Emerging Implant Technologies GmbH: 3 (https://510kreport.com/company/eit-emerging-implant-technologies)
- Amendia, Inc.: 3 (https://510kreport.com/company/amendia)
- Nexxt Spine, LLC: 2 (https://510kreport.com/company/nexxt-spine)
- Globus Medical, Inc.: 2 (https://510kreport.com/company/globus-medical)
- Depuy Spine, A Johnson & Johnson Company: 2 (https://510kreport.com/company/depuy-spine-a-johnson-johnson)

## Firms that cite its devices most
- Zavation Medical Products, LLC: 1 (https://510kreport.com/company/zavation-medical-products)
- Gbs Commonwealth Co., Ltd.: 1 (https://510kreport.com/company/gbs-commonwealth)
- NanoHive Medical, LLC: 1 (https://510kreport.com/company/nanohive-medical)
- Icotec AG: 1 (https://510kreport.com/company/icotec)
- Alphatec Spine, Inc.: 1 (https://510kreport.com/company/alphatec-spine)
- Medyssey Co, Ltd.: 1 (https://510kreport.com/company/medyssey)

## Its most-cited devices
- K180337: EUROPA Pedicle Screw System (2019), cited by 4
- K191906: MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF (2020), cited by 3
- K182970: EUROPA™ Pedicle Screw System (2019), cited by 2
- K182920: MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar Interbody Fusion (PLIF); HYPERION™ PEEK Transforaminal Lumbar Interbody Fusion (TLIF); CALPYSO™ PEEK Lateral Lumbar Interbody Fusion (LLIF); ANTARES™ PEEK Anterior Lumbar Interbody Fusion (ALIF) (2019), cited by 2
- K210800: IO Expandable Lumbar Interbody Fusion System (2021), cited by 2
- K232348: RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System (2023), cited by 1

## Recent decisions
- K253444: EUROPA™ Posterior Cervical Fusion Navigated Instruments (Mar 18, 2026)
- K252733: ATLAS™ Expandable Osteotomy Wedge System (Feb 19, 2026)
- K242516: EUROPA™ Posterior Cervical Fusion System (Nov 19, 2024)
- K241175: MiRus MoRe Lumbar Plating System (May 17, 2024)
- K232348: RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System (Oct 27, 2023)
- K232481: RIGEL™ 3DR Anterior Cervical Corpectomy System (Oct 13, 2023)
- K232154: MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation (Sep 11, 2023)
- K230369: EUROPA™ Navigated Instruments (Jun 23, 2023)

Source page: https://510kreport.com/company/mirus