# K143100: NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System Genta

- Pathway: 510(k) (Traditional)
- Applicant: Cossington, Ltd.
- Decided: Mar 5, 2015 after 128 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: 4 generations back to K000943 (2001). 4 ancestors in all.
12 later devices descend from it; 3 cite it directly.
0 of 17 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 5.
- K092773: Cemex Genta, Genta System and Genta System Fast, Tecres S.P.A. (2009) Summary page 5.

## Most influential descendants
- 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
- K253675: OsteoRemedies Hip Spacer System (2025), 1 descendant of its own
- K231556: SPECTRUM® GV Bone Cement (2023), 1 descendant of its own

## Indications for use
NP Cements Genta / NP Cement System Genta are intended for the fixation of prosthesis 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/K143100
Methodology: https://510kreport.com/methodology