510(k) Report

FDA applicant

Topez Orthopedics, Inc.

Boulder, CO1 decision2005–20054 recalls

FDA records 1 decision for Topez Orthopedics, Inc. (Boulder, CO) in 2005: 1 510(k) clearance. All are in product code HSN (Prosthesis, Ankle, Semi-Constrained, Cemented…). Its devices cite 1 predicate, 0 of them its own earlier devices. 4 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 Topez Orthopedics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Topez Orthopedics, Inc. since 2007.

Recalls per year

2in 2022

2016: 12020: 12022: 2
2007high 2 (2022) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Topez Orthopedics, 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?

  • HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1decision

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 9 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.

  • K051023Topez Total Ankle ReplacementTopez Orthopedics, Inc. · 20059cite it

What has FDA decided for it lately?

  • K051023Topez Total Ankle ReplacementTopez Orthopedics, Inc. · 20054 recalls

The one decision as Topez Orthopedics, Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K051023Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF…Sep 30, 2022Class II
  • K051023Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF…Sep 30, 2022Class II
  • K051023WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Product Usage…Apr 9, 2020Class II
  • K051023INBONE STEM, TIBIAL, TOP, Part Number 200011901Nov 8, 2016Class II