# K150850: Refobacin Bone Cement R

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jul 16, 2015 after 107 days
- Product code: MBB (Bone Cement, Antibiotic)
- 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: 2 generations back to P810020 (1984). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031673: Refobacin -Palacos G, Heraeus Kulzer GmbH & Co. KG (2004) Summary page 4.

## Indications for use
Refobacin Bone Cement R is indicated for use as bone cement in arthroplasty procedures of the hip, knee, and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. 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.

Source page: https://510kreport.com/device/K150850
Methodology: https://510kreport.com/methodology