510(k) Report

510(k) · Cleared

Cleared

Cemex System Genta Fast Bone Cement

K043403510(k) SpecialCleared Dec 28, 200418-day reviewClass II21 CFR 888.3027

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Exactech, Inc. · LOD Bone Cement

Cleared on Dec 28, 2004 as substantially equivalent to K033596 (Exactech, Inc., 2004) after an 18-day review. Its family tree reaches back 2 generations to 2001. 15 later devices descend from it.

Decided
Dec 28, 2004
Review
18 days
Class
Class II
Product code
LOD
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K000943 (2001). 15 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2015: 1 descendant cleared2024: 2 descendants cleared2023: 3 descendants cleared2021: 1 descendant cleared2018: 1 descendant cleared2025: 3 descendants cleared2020: 1 descendant cleared2019: 1 descendant cleared2026: 1 descendant clearedK000943 · Cemex System Gun Application Version · Exactech, Inc. · 2001K033596 · Cemex Genta Bone Cement; Cemex Genta System Bone Cement · Exactech, Inc. · 2004200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 3 descendants4 generations forward: 6 descendants5 generations forward: 3 descendants K033596 · Cemex Genta Bone Cement; Cemex Genta System Bone Cement · Exactech, Inc. · 2004K000943 · Cemex System Gun Application Version · Exactech, Inc. · 20010+5
  1. Root · 2 generations backK000943 Cemex System Gun Application VersionExactech, Inc. · 2001
  2. 1 generation backK033596 Cemex Genta Bone Cement; Cemex Genta System Bone CementExactech, Inc. · 2004
  3. This deviceK043403 Cemex System Genta Fast Bone CementExactech, Inc. · 2004
  4. Descendant · cites it directly · 14 of its ownK092773 Cemex Genta, Genta System and Genta System FastTecres S.P.A. · 2009
  5. Descendant · 2 generations on · 12 of its ownK143100 NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP…Cossington, Ltd. · 2015
  6. Descendant · 3 generations on · 9 of its ownK172906 REMEDY PLUS Hip Spacer, UNITE PLUS Bone CementOsteoremedies, LLC · 2018
  7. Descendant · 4 generations on · 4 of its ownK191981 REMEDY Acetabular CupOsteoremedies, LLC · 2019
  8. Descendant · 4 generations on · 2 of its ownK192995 OsteoRemedies Hip Spacer SystemOsteoremedies, LLC · 2020

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2009: 12015: 12018: 12019: 12020: 12021: 12023: 32024: 22025: 32026: 1
2009high 3 (2023) · low 0 (2010)2026

Most influential descendants

Showing 5 of 15 · See all
  • K092773Cemex Genta, Genta System and Genta System FastTecres S.P.A. · 2009 · cites it directly14descendants
  • K143100NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System GentaCossington, Ltd. · 2015 · 2 generations on12descendants
  • K172906REMEDY PLUS Hip Spacer, UNITE PLUS Bone CementOsteoremedies, LLC · 2018 · 3 generations on9descendants
  • K191981REMEDY Acetabular CupOsteoremedies, LLC · 2019 · 4 generations on4descendants
  • K192995OsteoRemedies Hip Spacer SystemOsteoremedies, LLC · 2020 · 4 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K000943Cemex System Gun Application VersionExactech, Inc.2001—
−1K033596Cemex Genta Bone Cement; Cemex Genta System Bone CementExactech, Inc.2004—
0 (this device)K043403Cemex System Genta Fast Bone CementExactech, Inc.2004—
+1K092773Cemex Genta, Genta System and Genta System FastTecres S.P.A.2009—
+2K143100NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV…Cossington, Ltd.2015—
+3K172906REMEDY PLUS Hip Spacer, UNITE PLUS Bone CementOsteoremedies, LLC2018—
+4K191981REMEDY Acetabular CupOsteoremedies, LLC2019—
+4K192995OsteoRemedies Hip Spacer SystemOsteoremedies, LLC2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201510
201810
201910
202010
202110
202330
202420
202530
202610
FIG. 1 — Lineage of K043403, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K254107 Refobacin Bone Cement R (110034355)score 11.8 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K033596Cemex Genta Bone Cement; Cemex Genta System Bone Cement
Summary page 1
…rer 510 k) Number Cemex Genta Tecres, S.p.A. #K033596 Cemex System Genta INDICATIONS FOR USE Cem…
Exactech, Inc.2004—

Also cleared against K033596: 2 other devices →

What descends from it? (15)

See all 15

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K092773Cemex Genta, Genta System and Genta System FastTecres S.P.A.200914

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 3 years and passes through 1 company; a new generation was cleared every 3.2 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K092773 (Tecres S.P.A., 2009) has gone furthest, with 14 descendants of its own.
  • 2 other devices also cite its predicate K033596.

How does its category compare?

All LOD devices

LOD Bone Cement: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LOD

1in 2025

2007: 22008: 12009: 32013: 22014: 12015: 42016: 12017: 32018: 22019: 42020: 32021: 42022: 32023: 22024: 12025: 12026 (partial year): 1
2007high 4 (2015) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LOD

277in 2022

2009: 103 days median2015: 138 days median2017: 96 days median2019: 90 days median2020: 139 days median2021: 95 days median2022: 277 days median
2007high 277 (2022) · low 90 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LOD

2in 2022

2014: 12017: 42020: 12022: 22026 (partial year): 2
2007high 4 (2017) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LOD

355in 2025

2007: 782008: 1342009: 1702010: 2912011: 4282012: 4122013: 5012014: 4652015: 5292016: 6152017: 8172018: 1,2952019: 2,3072020: 1,2942021: 7822022: 4722023: 4752024: 4922025: 355
2007high 2,307 (2019) · low 78 (2007)2025

MAUDE reports naming product code LOD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—078
20081—0134
200931030170
20100—0291
20110—0428
20120—0412
20132—0501
20141—1465
201541380529
20161—0615
20173964817
20182—01,295
201949002,307
2020313911,294
20214950782
202232772472
20232—0475
20241—0492
20251—0355
20261—2—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

Also cleared against K033596

2 other devices cite the same predicate.

  • K143100NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System GentaCossington, Ltd. · 2015
  • K092773Cemex Genta, Genta System and Genta System FastTecres S.P.A. · 2009

More from Exactech, Inc.

207 FDA decisions under this applicant name. See the company

  • K260583Equinoxe® Shoulder SystemExactech, Inc. · 2026
  • K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc. · 2025
  • K243448Equinoxe® Shoulder SystemExactech, Inc. · 2025
  • K243275Equinoxe® Scapula Fracture SystemExactech, Inc. · 2025
  • K243839Alteon® HA Femoral StemsExactech, Inc. · 2025

Recent decisions in LOD

The LOD category page

  • K254107Refobacin Bone Cement R (110034355)Biomet France · 2026
  • K250760SPECTRUM GV Bone CementOsteoremedies, LLC · 2025
  • K241674Osteopal® VHeraeus Medical GmbH · 2024
  • K231556SPECTRUM® GV Bone CementOsteoremedies, LLC · 2023
  • K211163Bone Cement Genta, Bone Cement HV, Bone Cement LVTecres S.P.A. · 2023

https://510kreport.com/device/K043403 · printed Nov 4, 2026

Cite this page

510(k) Report. “K043403: Cemex System Genta Fast Bone Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043403

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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