510(k) Report

FDA applicant

X-Sten Corp.

San Jose, CA2 decisions2006–20100 recalls

FDA records 2 decisions for X-Sten Corp. (San Jose, CA) from 2006 to 2010: 2 510(k) clearances. All are in product code HRX (Arthroscope). Its devices cite 13 predicates, 1 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 X-Sten Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — X-Sten Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like X-Sten Corp.’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?

  • HRXArthroscope2decisions

Whose devices does it build on?

Its devices cite 13 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 1 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.

  • K093062Vertos Medical Mild Device KitX-Sten Corp. · 20104cite it
  • K062038X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 20061cites it

What has FDA decided for it lately?

  • K093062Vertos Medical Mild Device KitX-Sten Corp. · 2010
  • K062038X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006

All 2 as X-Sten Corp. →