ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System
FDA 510(k) K220115 · MiRus, LLC
510(k) numberK220115
Submission
- Device name
- ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System
- Applicant
- MiRus, LLC
Marietta, GA, US - Received
- January 14, 2022
- Decision date
- May 13, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
Other 510(k)s with product code OVD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262025 | Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…OVD · Traditional | INNO Holdings Inc. DBA Innovasis | 09/11/2026SE |
| K261408 | SABER-XA SystemOVD · Traditional | Elevation Spine | 08/03/2026SE |
| K261809 | Interwedge® Standalone LateralOVD · Special | Foundation Surgical Group | 07/31/2026SE |
| K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…OVD · Traditional | Kyocera Medical Technologies, Inc. | 07/15/2026SE |
| K260810 | Anteralign LS coverplateOVD · Traditional | Tyber Medical, LLC | 06/10/2026SE |
| K254202 | MectaLIF 3D Metal AnteriorOVD · Traditional | Medacta International S.A. | 05/05/2026SE |
| K253401 | SCRIPT Implant SystemOVD · Traditional | Globus Medical, Inc. | 04/29/2026SE |
| K253559 | Ventana A Anterior Lumbar Interbody SystemOVD · Traditional | Spinal Elements, Inc. | 02/25/2026SE |
| K251829 | DeGen Medical Patient Specific Implant (PSI) SystemOVD · Traditional | Degen Medical | 12/08/2025SE |
| K251575 | IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody SystemOVD · Traditional | Alphatec Spine | 09/03/2025SE |
More from Alphatec Spine
| 510(k) | Device | Decision |
|---|---|---|
| K253444 | EUROPA Posterior Cervical Fusion Navigated InstrumentsOLO · Traditional | 03/18/2026SE |
| K252733 | ATLAS Expandable Osteotomy Wedge SystemPLF · Traditional | 02/19/2026SE |
| K242516 | EUROPA Posterior Cervical Fusion SystemNKG · Traditional | 11/19/2024SE |
| K241175 | MiRus MoRe Lumbar Plating SystemKWQ · Traditional | 05/17/2024SE |
| K232348 | RIGEL 3DR Standalone Anterior Cervical Interbody Fusion SystemOVE · Traditional | 10/27/2023SE |
| K232481 | RIGEL 3DR Anterior Cervical Corpectomy SystemPLR · Traditional | 10/13/2023SE |
| K232154 | MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationOVD · Traditional | 09/11/2023SE |
| K230369 | EUROPA Navigated InstrumentsOLO · Traditional | 06/23/2023SE |
| K220441 | CYGNUS MoRe Anterior Cervical Plate SystemKWQ · Traditional | 09/16/2022SE |
| K210800 | IO Expandable Lumbar Interbody Fusion SystemMAX · Traditional | 08/20/2021SE |
Questions and answers
When was ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System cleared by the FDA?
ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System (K220115) received a 510(k) decision of Substantially Equivalent on May 13, 2022, 119 days after the submission was received.
What is the product code of K220115?
The FDA product code is OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.