# K000943: Cemex System Gun Application Version

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Feb 8, 2001 after 322 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
No predicates in its family tree.
29 later devices descend from it; 5 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K033596: Cemex Genta Bone Cement; Cemex Genta System Bone Cement (2004), 16 descendants of its own
- K043403: Cemex System Genta Fast Bone Cement (2004), 15 descendants of its own
- 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

Source page: https://510kreport.com/device/K000943
Methodology: https://510kreport.com/methodology