510(k) Report

FDA applicant

Fxdevices

Boca Raton, FL4 decisions2007–20100 recalls

FDA records 4 decisions for Fxdevices (Boca Raton, FL) from 2007 to 2010: 4 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and KCT (Sterilization Wrap Containers, Trays…). Its devices cite 5 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 Fxdevices’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007: 12008: 12009: 12010: 1
2007high 1 (2007) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Which product codes does it file in?

  • HWCScrew, Fixation, Bone3decisions
  • KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories1decision

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 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.

  • K080649Pogo ScrewFxdevices · 20084cite it
  • K092189Pogo ScrewFxdevices · 20091cites it

What has FDA decided for it lately?

  • K091806Pogo Screw Instrumentation TrayFxdevices · 2010
  • K092189Pogo ScrewFxdevices · 2009
  • K080649Pogo ScrewFxdevices · 2008
  • K070393Lagwire SystemFxdevices · 2007

All 4 as Fxdevices →