510(k) · Cleared
ClearedCemex Genta, Genta System and Genta System Fast
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tecres S.P.A. · LOD Bone Cement
Cleared on Nov 24, 2009 as substantially equivalent to K033596 (Exactech, Inc., 2004) and 1 other predicate after a 76-day review. Its family tree reaches back 3 generations to 2001. 14 later devices descend from it.
- Decided
- Nov 24, 2009
- Review
- 76 days
- Class
- Class II
- Product code
- LOD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K000943 (2001). 14 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK000943 Cemex System Gun Application VersionExactech, Inc. · 2001
- 2 generations backK033596 Cemex Genta Bone Cement; Cemex Genta System Bone CementExactech, Inc. · 2004
- 1 generation backK043403 Cemex System Genta Fast Bone CementExactech, Inc. · 2004
- This deviceK092773 Cemex Genta, Genta System and Genta System FastTecres S.P.A. · 2009
- Descendant · cites it directly · 12 of its ownK143100 NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP…Cossington, Ltd. · 2015
- Descendant · 2 generations on · 9 of its ownK172906 REMEDY PLUS Hip Spacer, UNITE PLUS Bone CementOsteoremedies, LLC · 2018
- Descendant · 3 generations on · 4 of its ownK191981 REMEDY Acetabular CupOsteoremedies, LLC · 2019
- Descendant · 3 generations on · 2 of its ownK192995 OsteoRemedies Hip Spacer SystemOsteoremedies, LLC · 2020
- Descendant · 3 generations on · 1 of its ownK253675 OsteoRemedies Hip Spacer SystemOsteoremedies, LLC · 2025
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K143100NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System GentaCossington, Ltd. · 2015 · cites it directly12descendants
- K172906REMEDY PLUS Hip Spacer, UNITE PLUS Bone CementOsteoremedies, LLC · 2018 · 2 generations on9descendants
- K191981REMEDY Acetabular CupOsteoremedies, LLC · 2019 · 3 generations on4descendants
- K192995OsteoRemedies Hip Spacer SystemOsteoremedies, LLC · 2020 · 3 generations on2descendants
- K253675OsteoRemedies Hip Spacer SystemOsteoremedies, LLC · 2025 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000943 | Cemex System Gun Application Version | Exactech, Inc. | 2001 | — |
| −2 | K033596 | Cemex Genta Bone Cement; Cemex Genta System Bone Cement | Exactech, Inc. | 2004 | — |
| −1 | K043403 | Cemex System Genta Fast Bone Cement | Exactech, Inc. | 2004 | — |
| 0 (this device) | K092773 | Cemex Genta, Genta System and Genta System Fast | Tecres S.P.A. | 2009 | — |
| +1 | K143100 | NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV… | Cossington, Ltd. | 2015 | — |
| +2 | K172906 | REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement | Osteoremedies, LLC | 2018 | — |
| +3 | K191981 | REMEDY Acetabular Cup | Osteoremedies, LLC | 2019 | — |
| +3 | K192995 | OsteoRemedies Hip Spacer System | Osteoremedies, LLC | 2020 | — |
| +3 | K253675 | OsteoRemedies Hip Spacer System | Osteoremedies, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 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 2…nta System and Cemex Genta System Fast bone cements are substantially equivalent to the following predicate devices: * Cemex Genta and Cemex Genta System cleared via K033596 a Cemex Genta System Fast cleared via K043403 SUBSTANTIAL EQUIVALENCE: Performance testing was conducted to verify that the… | 2004 |
| * | K043403 | Cemex System Genta Fast Bone CementSummary page 2…ts are substantially equivalent to the following predicate devices: * Cemex Genta and Cemex Genta System cleared via K033596 a Cemex Genta System Fast cleared via K043403 SUBSTANTIAL EQUIVALENCE: Performance testing was conducted to verify that the modified bone cement performance continue to be… | 2004 |
What descends from it? (14)
See all 142 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 8 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K143100 (Cossington, Ltd., 2015) has gone furthest, with 12 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. 2009, 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?
Cemex Genta/Cemex Genta System/Cemex Genta System 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092773 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092773: Cemex Genta, Genta System and Genta System Fast.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092773
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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