510(k) Report

FDA applicant

Arthex, Inc.

Naples, FL3 decisions2015–20236 recalls

FDA records 3 decisions for Arthex, Inc. (Naples, FL) from 2015 to 2023: 3 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and PLF (Bone Wedge). Its devices cite 7 predicates, 0 of them its own earlier devices. 6 recalls are linked to its devices.

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 Arthex, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2015: 12017: 12023: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

6in 2016

2016: 6
2015high 6 (2016) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Arthex, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Arthex, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GCJLaparoscope, General & Plastic Surgery1decision
  • PLFBone Wedge1decision
  • MBIFastener, Fixation, Nondegradable, Soft Tissue1decision

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K151256Arthrex BioSync® Bone WedgeArthex, Inc. · 20153cite it
  • K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc. · 20231cites it

What has FDA decided for it lately?

  • K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc. · 2023
  • K172612FiberTak DXArthex, Inc. · 2017
  • K151256Arthrex BioSync® Bone WedgeArthex, Inc. · 20156 recalls

All 3 as Arthex, Inc. →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K151256BioSync Anatomic Cotton Wedge, 16 x 6.5 mm.; Used for internal bone fixation for bone…Apr 22, 2016Class II
  • K151256BioSync Anatomic Cotton Wedge, 20 x 5.5 mm.; Used for internal bone fixation for bone…Apr 22, 2016Class II
  • K151256BioSync Anatomic Cotton Wedge, 16 x 4.5 mm.; Used for internal bone fixation for bone…Apr 22, 2016Class II
  • K151256BioSync Anatomic Cotton Wedge, 20 x 6.5 mm.; Used for internal bone fixation for bone…Apr 22, 2016Class II
  • K151256BioSync Anatomic Cotton Wedge, 20 x 4.5 mm.; Used for internal bone fixation for bone…Apr 22, 2016Class II
  • K151256BioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation for bone…Apr 22, 2016Class II