Refobacin Bone Cement R (110034355)— 510(k) K254107

Name: FDA 510(k) clearance K254107
Creator: U.S. Food and Drug Administration
Published: 2026-04-15

Substantially Equivalent

Biomet France

FDA 510(k) clearance K254107 for Refobacin Bone Cement R (110034355), Substantially Equivalent on 2026-04-15. Applicant: Biomet France. Device class: 2.

Summary

Biomet France's Refobacin Bone Cement R (110034355) is filed under product code LOD (Bone Cement).

Class II, 21 CFR 888.3027. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Biomet France filed from Valence, France. The decision came 117 calendar days after FDA received it (December 19, 2025 to April 15, 2026).

Clearance details

Applicant: Biomet France
Product code: Product code LOD
Device class: Class 2
Regulation: 21 CFR 888.3027
Advisory panel: Orthopedic
Date received: 2025-12-19
Decision date: 2026-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valence, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code LOD

view all

K250760 — SPECTRUM GV Bone Cement2025-04-02
K241674 — OSTEOPAL® V2024-12-05
K231556 — SPECTRUM® GV Bone Cement2023-12-20
K211163 — Bone Cement Genta, Bone Cement HV, Bone Cement LV2023-01-09
K212729 — Bone Cement-Normal Viscosity2022-05-31

Adverse events under product code LOD

product code LOD

Death: 44
Injury: 3,004
Malfunction: 895
Other: 4
Total: 3,947

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.