REFOBACIN -PALACOS G— 510(k) K031673

Clearance details

Applicant

Heraeus Kulzer GmbH & Co. KG

Product code

Code LOD

Device class

Class 2

Regulation

21 CFR 888.3027

Advisory panel

Orthopedic

Date received

2003-05-30

Decision date

2004-05-25

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hanau, DE

• K254107 — Refobacin Bone Cement R (110034355)2026-04-15
• 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

• K030902 — PALACOS R2003-09-23
• K030903 — OSTEOPAL2003-09-23
• K022251 — PALABOND2003-02-26

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 →

• Z-0730-2014 — Palacos¿ R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 g Methyl Acrylate Copolymer, 20 ml Methyl Methacrylate Monomer 0.5 g Gentamicin, Distributed by Zimmer Dover, OH 44522 The cement is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.Class II·Terminated·Zimmer, Inc.·20131104

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K031673.