510(k) Report

FDA applicant

Arex USA

Collegeville, PA3 decisions2008–20130 recalls

FDA records 3 decisions for Arex USA (Collegeville, PA) from 2008 to 2013: 3 510(k) clearances. Most are in product codes HTY (Pin, Fixation, Smooth) and HWC (Screw, Fixation, Bone). Its devices cite 5 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Arex USA, 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 Arex USA’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2008: 12010: 12013: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Arex USA by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Arex USA’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?

  • HTYPin, Fixation, Smooth2decisions
  • HWCScrew, Fixation, Bone1decision

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K094043LigamentotaxorArex USA · 20102cite it
  • K081011Arex Scru 2 Headless Compression Screws, Models: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45Arex USA · 20081cites it

What has FDA decided for it lately?

  • K122415X-Fix Dynamic External DistractorArex USA, LLC · 2013
  • K094043LigamentotaxorArex USA · 2010
  • K081011Arex Scru 2 Headless Compression Screws, Models: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45Arex USA · 2008

All 2 as Arex USA →The one decision as Arex USA, LLC →