# K081163: Smartset GMV Gentamicin Bone Cement

- Pathway: 510(k) (Special)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: May 14, 2008 after 20 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: 4 generations back to P810020 (1984). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041656: Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV Endurance Gentamicin Bone Cement, DePuy Orthopaedics, Inc. (2004) Summary page 1.
- K033563: Smartset GHV Gentamicin Bone Cement, DePuy Orthopaedics, Inc. (2004) Summary page 1.

## Indications for use
SmartSet GMV Gentamicin Bone 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/K081163
Methodology: https://510kreport.com/methodology