# K043403: Cemex System Genta Fast Bone Cement

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Dec 28, 2004 after 18 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: 2 generations back to K000943 (2001). 2 ancestors in all.
15 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033596: Cemex Genta Bone Cement; Cemex Genta System Bone Cement, Exactech, Inc. (2004) Summary page 1.

## Most influential descendants
- K092773: Cemex Genta, Genta System and Genta System Fast (2009), 14 descendants of its own
- K143100: NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System Genta (2015), 12 descendants of its own
- K172906: REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement (2018), 9 descendants of its own
- K191981: REMEDY Acetabular Cup (2019), 4 descendants of its own
- K192995: OsteoRemedies Hip Spacer System (2020), 2 descendants of its own

## Indications for use
Cemex System Genta Fast Bone Cement is indicated for the fixation of prostheses 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/K043403
Methodology: https://510kreport.com/methodology