510(k) Report

FDA applicant

Orthoxel

Bishopstown, IE2 decisions2017–20180 recalls

FDA records 2 decisions for Orthoxel (Bishopstown, IE) from 2017 to 2018: 2 510(k) clearances. All are in product code HSB (Rod, Fixation, Intramedullary And Accessories). Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is 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 Orthoxel’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2017: 12018: 1
2017high 1 (2017) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Orthoxel by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HSBRod, Fixation, Intramedullary And Accessories2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K170972Apex Tibial Nailing SystemOrthoxel · 20171cites it

What has FDA decided for it lately?

  • K181375Apex Femoral Nailing SystemOrthoxel · 2018
  • K170972Apex Tibial Nailing SystemOrthoxel · 2017

All 2 as Orthoxel →

Other applicant names beginning “Orthoxel”

FDA records each applicant name separately; these may or may not be the same firm.

Orthoxel Dac 1