510(k) Report

FDA applicant

Djo Global

Austin2 decisions2009–20142 recalls

FDA records 2 decisions for Djo Global (Austin) from 2009 to 2014: 1 510(k) clearance and 1 original PMA approval. Most are in product codes NTG (Prosthesis, Ankle, Uncemented, Non-Constrained) and PHX (Shoulder Prosthesis, Reverse Configuration). Its devices cite 7 predicates, 0 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 Djo Global’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2009: 12014: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

2in 2020

2020: 2
2009high 2 (2020) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Djo Global by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NTGProsthesis, Ankle, Uncemented, Non-Constrained1decision
  • PHXShoulder Prosthesis, Reverse Configuration1decision

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 0 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.

  • K141006RSP Humeral Socket InsertDjo Global · 20144cite it

What has FDA decided for it lately?

  • K141006RSP Humeral Socket InsertDjo Global · 20142 recalls
  • P050050Scandinavian Total Ankle Replacement System (S.T.a.R.Ankle)Djo Global · 2009

All 2 as Djo Global →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K141006RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044Aug 7, 2020Class II
  • K141006RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440Aug 7, 2020Class II