510(k) Report

FDA applicant

Endomedics, Inc.

Walker, MI4 decisions1984–19843 recalls

FDA records 4 decisions for Endomedics, Inc. (Walker, MI) in 1984: 4 510(k) clearances. Most are in product codes JDL (Prosthesis, Hip, Semi-Constrained (Metal…) and KWL (Prosthesis, Hip, Hemi-, Femoral, Metal). 3 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 Endomedics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Endomedics, Inc. since 2007.

Recalls per year

3in 2009

2009: 3
2007high 3 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Endomedics, 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?

  • JDLProsthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)1decision
  • KWLProsthesis, Hip, Hemi-, Femoral, Metal1decision
  • JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1decision
  • KXAProsthesis, Hip, Femoral, Resurfacing1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K842202New Jersey Acetabular Component &Endomedics, Inc. · 19841cites it

What has FDA decided for it lately?

  • K831792Self-Aligning Acetabular ComponentEndomedics, Inc. · 1984
  • K842234New Jersey Femoral StemEndomedics, Inc. · 19843 recalls
  • K842202New Jersey Acetabular Component &Endomedics, Inc. · 1984
  • K842233New Jersey Femoral Resurfacing ComponentEndomedics, Inc. · 1984

All 4 as Endomedics, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K842234Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System. BP Ankle System…Jun 5, 2009
  • K842234Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System. BP Ankle System…Jun 5, 2009
  • K842234Endotec Prothesis Ankle, Titanium Alloy, Sterilized. BP Ankle System, Talar Ankle…Jun 5, 2009