510(k) Report

FDA applicant

Global Manufacturing Technology

Washington, DC3 decisions2011–20130 recalls

FDA records 3 decisions for Global Manufacturing Technology (Washington, DC) from 2011 to 2013: 3 510(k) clearances. Most are in product codes MEH (Prosthesis, Hip, Semi-Constrained, Uncemented…) and LZO (Prosthesis, Hip, Semi-Constrained…). Its devices cite 11 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 Global Manufacturing Technology’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2011: 22013: 1
2011high 2 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Global Manufacturing Technology 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?

  • MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium…2decisions
  • LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous…1decision

Whose devices does it build on?

Its devices cite 11 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.

  • K102172Msa Hip SystemGlobal Manufacturing Technology · 20112cite it
  • K123782Paragon Hip SystemGlobal Manufacturing Technology · 20131cites it

What has FDA decided for it lately?

  • K123782Paragon Hip SystemGlobal Manufacturing Technology · 2013
  • K113107Msa Hip SystemGlobal Manufacturing Technology · 2011
  • K102172Msa Hip SystemGlobal Manufacturing Technology · 2011

All 3 as Global Manufacturing Technology →