510(k) Report

FDA applicant

Biologically Oriented Prostheses

Port Huron, MI9 decisions1995–20001 recall

FDA records 9 decisions for Biologically Oriented Prostheses (Port Huron, MI) from 1995 to 2000: 9 510(k) clearances. Most are in product codes LZO (Prosthesis, Hip, Semi-Constrained…) and LPH (Prosthesis, Hip, Semi-Constrained…). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 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 Biologically Oriented Prostheses’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biologically Oriented Prostheses since 2007.

Recalls per year

1in 2025

2025: 1
2007high 1 (2025) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Biologically Oriented Prostheses 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?

  • LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous…3decisions
  • LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented2decisions
  • JDCProsthesis, Elbow, Constrained, Cemented1decision
  • KYIProsthesis, Wrist, Carpal Trapezium1decision
  • JDSNail, Fixation, Bone1decision
  • JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K962769Horizon Hip SystemBiologically Oriented Prostheses · 19962cite it
  • K955916Townley Total Elbow SystemBiologically Oriented Prostheses · 19961cites it
  • K964472Riopro Cobalt Trapeziometarcarpal Resurfacing ComponentBiologically Oriented Prostheses · 19971cites it
  • K002325Wujin #3 Tibial NailBiologically Oriented Prostheses · 20001cites it

What has FDA decided for it lately?

  • K002325Wujin #3 Tibial NailBiologically Oriented Prostheses · 2000
  • K992144Biopro Rimmed Acetabular CompomentBiologically Oriented Prostheses · 1999
  • K964472Riopro Cobalt Trapeziometarcarpal Resurfacing ComponentBiologically Oriented Prostheses · 1997
  • K962769Horizon Hip SystemBiologically Oriented Prostheses · 1996
  • K955916Townley Total Elbow SystemBiologically Oriented Prostheses · 1996
  • K954768Biopro Hemi-Endo Modular Ceramic HeadBiologically Oriented Prostheses · 19961 recall
  • K952731Townley All Poly Acetabular CupBiologically Oriented Prostheses · 1995
  • K953045Biopro Hemi-Endo Modular Ceramic HeadBiologically Oriented Prostheses · 1995

All 9 as Biologically Oriented Prostheses →

What has been recalled?

1 recall linked to its devices; the latest:

  • K954768BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012…Sep 9, 2025Class II