510(k) Report

FDA applicant

Orchard Medical Development, LLC

Rosemont, IL2 decisions2024–20241 recall

FDA records 2 decisions for Orchard Medical Development, LLC (Rosemont, IL) in 2024: 2 510(k) clearances. All are in product code LZO (Prosthesis, Hip, Semi-Constrained…). Its devices cite 3 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Orchard Medical Development”.

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 Orchard Medical Development, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2024: 2
2024high 2 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1
2024high 1 (2025) · low 0 (2024)2026

Class I Class II/III not classified

FIG. 1 — Orchard Medical Development, LLC by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous…2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K233476Z1 Hip SystemOrchard Medical Development · 20242cite it

What has FDA decided for it lately?

  • K241241Z1 Cemented Hip SystemOrchard Medical Development, LLC · 2024
  • K233476Z1 Hip SystemOrchard Medical Development · 20241 recall

The one decision as Orchard Medical Development, LLC →The one decision as Orchard Medical Development →

What has been recalled?

1 recall linked to its devices; the latest:

  • K233476Z1 Femoral Hip System, Product Number 611777612Feb 12, 2025Class II