Home / 510(k) Clearances / K240889

510(k) K240889

ARTFX Lumbar PEEK Cages by Artfx Medical — Product Code MAX

K240889 is an FDA 510(k) premarket notification submitted by Artfx Medical for the device "ARTFX Lumbar PEEK Cages". The FDA issued a decision of Substantially Equivalent on October 2, 2024. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Artfx Medical has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2024
Date Received
April 1, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other clearances by Artfx Medical

  • K242939 — ARTFX Trauma Bone Plate and Screw System (December 23, 2024)
  • K240893 — ARTFX MEDICAL Cervical PEEK Cages (June 28, 2024)
  • K212220 — ArtFX Spinal Fixation System (April 20, 2023)
  • K211718 — Venus Cervical Plate System (June 28, 2022)

Other clearances for product code MAX

  • K253151 — Fule Interbody Fusion Cage System (June 15, 2026)
  • K261159 — Exceed® Biplanar Expandable Interbody System (May 29, 2026)
  • K253894 — BMD Titanium Spinal Fusion System (May 28, 2026)
  • K260506 — Ventana® P/T Lumbar Interbody System (May 15, 2026)
  • K260837 — VersaLift Expandable System (May 12, 2026)
  • K260385 — aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and tran (May 9, 2026)
  • K261067 — BEE PLIF Cage (April 30, 2026)
  • K254017 — SWINGO-3D Lumbar Cage System (February 26, 2026)
  • K253583 — LUX Expandable Lumbar Interbody System (February 23, 2026)
  • K250773 — Luna® Ti Interbody Fusion System (February 4, 2026)

FDA data resources