510(k) Report

FDA applicant

Lepine Groupe Spa.

Sarasota, FL1 decision1999–19990 recalls

FDA records 1 decision for Lepine Groupe Spa. (Sarasota, FL) in 1999: 1 510(k) clearance. All are in product code JDI (Prosthesis, Hip, Semi-Constrained…). 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 Lepine Groupe Spa.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Lepine Groupe Spa. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Lepine Groupe Spa. 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?

  • JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1decision

What has FDA decided for it lately?

  • K992490B2C Hip SystemLepine Groupe Spa. · 1999

The one decision as Lepine Groupe Spa. →