510(k) · Cleared
ClearedNP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System Genta
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cossington, Ltd. · LOD Bone Cement
Cleared on Mar 5, 2015 as substantially equivalent to K033596 (Exactech, Inc., 2004) and 1 other predicate after a 128-day review. Its family tree reaches back 4 generations to 2001. 12 later devices descend from it.
- Decided
- Mar 5, 2015
- Review
- 128 days
- Class
- Class II
- Product code
- LOD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K000943 (2001). 12 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK000943 Cemex System Gun Application VersionExactech, Inc. · 2001
- 3 generations backK033596 Cemex Genta Bone Cement; Cemex Genta System Bone CementExactech, Inc. · 2004
- 2 generations backK043403 Cemex System Genta Fast Bone CementExactech, Inc. · 2004
- 1 generation backK092773 Cemex Genta, Genta System and Genta System FastTecres S.P.A. · 2009
- This deviceK143100 NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP…Cossington, Ltd. · 2015
- Descendant · cites it directly · 9 of its ownK172906 REMEDY PLUS Hip Spacer, UNITE PLUS Bone CementOsteoremedies, LLC · 2018
- Descendant · 2 generations on · 4 of its ownK191981 REMEDY Acetabular CupOsteoremedies, LLC · 2019
- Descendant · 2 generations on · 2 of its ownK192995 OsteoRemedies Hip Spacer SystemOsteoremedies, LLC · 2020
- Descendant · 2 generations on · 1 of its ownK253675 OsteoRemedies Hip Spacer SystemOsteoremedies, LLC · 2025
- Descendant · 2 generations on · 1 of its ownK231556 SPECTRUM® GV Bone CementOsteoremedies, LLC · 2023
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K172906REMEDY PLUS Hip Spacer, UNITE PLUS Bone CementOsteoremedies, LLC · 2018 · cites it directly9descendants
- K191981REMEDY Acetabular CupOsteoremedies, LLC · 2019 · 2 generations on4descendants
- K192995OsteoRemedies Hip Spacer SystemOsteoremedies, LLC · 2020 · 2 generations on2descendants
- K253675OsteoRemedies Hip Spacer SystemOsteoremedies, LLC · 2025 · 2 generations on1descendant
- K231556SPECTRUM® GV Bone CementOsteoremedies, LLC · 2023 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000943 | Cemex System Gun Application Version | Exactech, Inc. | 2001 | — |
| −3 | K033596 | Cemex Genta Bone Cement; Cemex Genta System Bone Cement | Exactech, Inc. | 2004 | — |
| −2 | K043403 | Cemex System Genta Fast Bone Cement | Exactech, Inc. | 2004 | — |
| −1 | K092773 | Cemex Genta, Genta System and Genta System Fast | Tecres S.P.A. | 2009 | — |
| 0 (this device) | K143100 | NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV… | Cossington, Ltd. | 2015 | — |
| +1 | K172906 | REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement | Osteoremedies, LLC | 2018 | — |
| +2 | K191981 | REMEDY Acetabular Cup | Osteoremedies, LLC | 2019 | — |
| +2 | K192995 | OsteoRemedies Hip Spacer System | Osteoremedies, LLC | 2020 | — |
| +2 | K253675 | OsteoRemedies Hip Spacer System | Osteoremedies, LLC | 2025 | — |
| +2 | K231556 | SPECTRUM® GV Bone Cement | Osteoremedies, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LOD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LOD device
- #1 K254107 Refobacin Bone Cement R (110034355)score 11.8 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K033596 | Cemex Genta Bone Cement; Cemex Genta System Bone CementSummary page 5…Orthopedic 3 PREDICATE DEVICE The predicate device is as follows: Tecres Cemex Genta HV, which was cleared originally through 510(k) application K033596 and then subsequently through 510(k) application K092773. 4 DEVICE DESCRIPTION The NP Cements Genta and NP Cements System Gen… | 2004 |
| * | K092773 | Cemex Genta, Genta System and Genta System FastSummary page 5…s as follows: Tecres Cemex Genta HV, which was cleared originally through 510(k) application K033596 and then subsequently through 510(k) application K092773. 4 DEVICE DESCRIPTION The NP Cements Genta and NP Cements System Genta are PMMA, radiopaque bone cements, containing gentamic… | 2009 |
What descends from it? (12)
See all 123 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K172906 (Osteoremedies, LLC, 2018) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K033596.
How does its category compare?
All LOD devicesLOD Bone Cement: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · LOD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LOD
277in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LOD
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LOD
355in 2025
MAUDE reports naming product code LOD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 78 |
| 2008 | 1 | — | 0 | 134 |
| 2009 | 3 | 103 | 0 | 170 |
| 2010 | 0 | — | 0 | 291 |
| 2011 | 0 | — | 0 | 428 |
| 2012 | 0 | — | 0 | 412 |
| 2013 | 2 | — | 0 | 501 |
| 2014 | 1 | — | 1 | 465 |
| 2015 | 4 | 138 | 0 | 529 |
| 2016 | 1 | — | 0 | 615 |
| 2017 | 3 | 96 | 4 | 817 |
| 2018 | 2 | — | 0 | 1,295 |
| 2019 | 4 | 90 | 0 | 2,307 |
| 2020 | 3 | 139 | 1 | 1,294 |
| 2021 | 4 | 95 | 0 | 782 |
| 2022 | 3 | 277 | 2 | 472 |
| 2023 | 2 | — | 0 | 475 |
| 2024 | 1 | — | 0 | 492 |
| 2025 | 1 | — | 0 | 355 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K143100 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143100: NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System Genta.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143100
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026