510(k) Report

FDA applicant

Valpo Orthopedic Technology, Inc.

Warsaw, IN2 decisions2006–20080 recalls

FDA records 2 decisions for Valpo Orthopedic Technology, Inc. (Warsaw, IN) from 2006 to 2008: 2 510(k) clearances. Most are in product codes HRY (Prosthesis, Knee, Femorotibial…) and JDR (Staple, Fixation, Bone). Its devices cite 6 predicates, 0 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 Valpo Orthopedic Technology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Valpo Orthopedic Technology, 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/Polymer1decision
  • JDRStaple, Fixation, Bone1decision

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K072704Unicompartmental KneeValpo Orthopedic Technology, Inc. · 2008
  • K062734Adjust-Right Fixation DevicesValpo Orthopedic Technology, Inc. · 2006

All 2 as Valpo Orthopedic Technology, Inc. →