# K242216: Gentafix®  (1, 3, 3MV)

- Pathway: 510(k) (Traditional)
- Applicant: Teknimed Sas
- Decided: Dec 18, 2024 after 142 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 K000943 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092773: Cemex Genta, Genta System and Genta System Fast, Tecres S.P.A. (2009) Summary page 6.

## Indications for use
GENTAFIX 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 intended for use to affix a new prosthesis in the second phase of a two-stage revision after the initial infection has been cleared.

Source page: https://510kreport.com/device/K242216
Methodology: https://510kreport.com/methodology