510(k) Report

FDA applicant

Global Orthopaedic Technology, USA, Inc.

Oviedo, FL3 decisions2004–20050 recalls

FDA records 3 decisions for Global Orthopaedic Technology, USA, Inc. (Oviedo, FL) from 2004 to 2005: 3 510(k) clearances. Most are in product codes HRY (Prosthesis, Knee, Femorotibial…) and KRR (Prosthesis, Knee, Patello/Femoral…). 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 Global Orthopaedic Technology, USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Global Orthopaedic Technology, USA, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer2decisions
  • KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer1decision

What has FDA decided for it lately?

  • K050473RBK Patella Femoral KneeGlobal Orthopaedic Technology, USA, Inc. · 2005
  • K051721Global Resurfacing Unicompartmental Knee SystemGlobal Orthopaedic Technology, USA, Inc. · 2005
  • K033351Global Resurfacing Unicompartmental (Gru) KneeGlobal Orthopaedic Technology, USA, Inc. · 2004

All 3 as Global Orthopaedic Technology, USA, Inc. →