510(k) Report

FDA applicant

Artfx Medical

Jacksonville, FL5 decisions2022–20240 recalls

FDA records 5 decisions for Artfx Medical (Jacksonville, FL) from 2022 to 2024: 5 510(k) clearances. Most are in product codes ODP (Intervertebral Fusion Device With Bone Graft…) and KWQ (Appliance, Fixation, Spinal Intervertebral Body). Since 2016 its 510(k)s took a median of 184 days from receipt to decision, against 85 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Artfx Medical, LLC”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Artfx Medical’s devices, and how often a recall has named them.

FDA decisions per year

3in 2024

2022: 12023: 12024: 3
2022high 3 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Artfx Medical by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision
  • KWQAppliance, Fixation, Spinal Intervertebral Body1decision
  • HRSPlate, Fixation, Bone1decision
  • NKBThoracolumbosacral Pedicle Screw System1decision
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 184 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 85 days; 1 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical · 20242cite it
  • K211718Venus Cervical Plate SystemArtfx Medical, LLC · 20222cite it
  • K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 20242cite it
  • K212220ArtFX Spinal Fixation SystemArtfx Medical, LLC · 20232cite it
  • K240889ARTFX Lumbar PEEK CagesArtfx Medical · 20242cite it

What has FDA decided for it lately?

  • K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024
  • K240889ARTFX Lumbar PEEK CagesArtfx Medical · 2024
  • K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical · 2024
  • K212220ArtFX Spinal Fixation SystemArtfx Medical, LLC · 2023
  • K211718Venus Cervical Plate SystemArtfx Medical, LLC · 2022

All 3 as Artfx Medical →All 2 as Artfx Medical, LLC →