510(k) Report

FDA applicant

Fx Solutions

Viriat, FR8 decisions2011–20172 recalls

FDA records 8 decisions for Fx Solutions (Viriat, FR) from 2011 to 2017: 8 510(k) clearances. Most are in product codes PHX (Shoulder Prosthesis, Reverse Configuration) and HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic…). Its devices cite 23 predicates, 9 of them its own earlier devices. 2 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 Fx Solutions’s devices, and how often a recall has named them.

FDA decisions per year

2in 2017

2011: 12013: 22014: 12015: 22017: 2
2011high 2 (2013) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

2in 2018

2018: 2
2011high 2 (2018) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Fx Solutions by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PHXShoulder Prosthesis, Reverse Configuration3decisions
  • HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented2decisions
  • KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2decisions
  • HRSPlate, Fixation, Bone1decision

Whose devices does it build on?

Its devices cite 23 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 30 times; 9 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.

  • K163669Humeris ShoulderFx Solutions · 20178cite it
  • K150488Humelock II Reversible Shoulder SystemFx Solutions · 20157cite it
  • K162455Humelock Reversed ShoulderFx Solutions · 20176cite it
  • K123814Humelock II Cemented Shoulder SystemFx Solutions · 20134cite it
  • K111097Humelock Cemented Shoulder ProsthesisFx Solutions · 20112cite it
  • K130759Humelock II Cementless Shoulder SystemFx Solutions · 20132cite it

What has FDA decided for it lately?

  • K163669Humeris ShoulderFx Solutions · 2017
  • K162455Humelock Reversed ShoulderFx Solutions · 2017
  • K150488Humelock II Reversible Shoulder SystemFx Solutions · 2015
  • K143721PRCT2Fx Solutions · 2015
  • K140071Humelock II Cemented Shoulder SystemFx Solutions · 2014
  • K130759Humelock II Cementless Shoulder SystemFx Solutions · 2013
  • K123814Humelock II Cemented Shoulder SystemFx Solutions · 2013
  • K111097Humelock Cemented Shoulder ProsthesisFx Solutions · 20112 recalls

All 8 as Fx Solutions →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K111097Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Product Usage: Device is designed to…Jun 4, 2018Class II
  • K111097Fx SOLUTIONS OFFSET HEAD CoCr 50x20, REF 106-5000 Product Usage: Device is designed to…Jun 4, 2018Class II