# K210125: BonOs HV Genta, BonOs MV Genta, BonOs LV Genta

- Pathway: 510(k) (Traditional)
- Applicant: Osartis GmbH
- Decided: Mar 19, 2021 after 59 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: 5 generations back to K000943 (2001). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143100: NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System Genta, Cossington, Ltd. (2015) Summary page 5.
- K031673: Refobacin -Palacos G, Heraeus Kulzer GmbH & Co. KG (2004) Summary page 5.

## Indications for use
BonOs® HV Genta, BonOs® MV Genta and BonOs® LV Genta are intended for the fixation of prothesis to living bone 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/K210125
Methodology: https://510kreport.com/methodology