Home / 510(k) Clearances / K220115

510(k) K220115

ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System by MiRus, LLC — Product Code OVD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2022
Date Received
January 14, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

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 clearances by MiRus, LLC

  • K252733 — ATLAS™ Expandable Osteotomy Wedge System (February 19, 2026)
  • K242516 — EUROPA™ Posterior Cervical Fusion System (November 19, 2024)
  • K241175 — MiRus MoRe Lumbar Plating System (May 17, 2024)
  • K232348 — RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System (October 27, 2023)
  • K232481 — RIGEL™ 3DR Anterior Cervical Corpectomy System (October 13, 2023)
  • K232154 — MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation (September 11, 2023)
  • K230369 — EUROPA™ Navigated Instruments (June 23, 2023)
  • K220441 — CYGNUS™ MoRe Anterior Cervical Plate System (September 16, 2022)
  • K210800 — IO Expandable Lumbar Interbody Fusion System (August 20, 2021)
  • K200685 — RIGEL 3DR Anterior Cervical Interbody Fusion System (June 11, 2020)

Other clearances for product code OVD

  • K253559 — Ventana™ A Anterior Lumbar Interbody System (February 25, 2026)
  • K251829 — DeGen Medical Patient Specific Implant (PSI) System (December 8, 2025)
  • K251575 — IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interb (September 3, 2025)
  • K250072 — CONDUIT™ SYNFIX™ Evolution Secured Spacer System (July 10, 2025)
  • K251644 — ProAM ALIF System (June 24, 2025)
  • K250845 — Curiteva Porous PEEK Standalone ALIF System (June 18, 2025)
  • K251459 — OneLIF™ Interbody Fusion System (June 12, 2025)
  • K243934 — Stable-L Lumbar Interbody System (April 30, 2025)
  • K243386 — Ventris Intervertebral Body Fusion Device (April 22, 2025)
  • K250603 — AxTiHA® Stand-Alone ALIF System (March 24, 2025)