# K254107: Refobacin Bone Cement R (110034355)

- Pathway: 510(k) (Traditional)
- Applicant: Biomet France
- Decided: Apr 15, 2026 after 117 days
- Product code: LOD (Bone Cement)
- Device class: 2
- Regulation: 21 CFR 888.3027
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to P810020 (1984). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171540: Refobacin Bone Cement R, Biomet, Inc. (2017) Summary page 5.

## Indications for use
Refobacin Bone Cement R is indicated to be used for stable anchoring of suitable joint prostheses to the bone, in hip and knee revision arthroplasty operations when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection, also in case an infection with gentamicin-sensitive strains is a potential risk. Refobacin Bone Cement R is indicated to be used in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

Source page: https://510kreport.com/device/K254107
Methodology: https://510kreport.com/methodology