510(k) Report

510(k) · Cleared

Cleared

Cemex Genta Bone Cement; Cemex Genta System Bone Cement

K033596510(k) TraditionalCleared May 10, 2004178-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 May 10, 2004 as substantially equivalent to K000943 (Exactech, Inc., 2001) after a 178-day review. Its family tree reaches back 1 generation to 2001. 16 later devices descend from it.

Decided
May 10, 2004
Review
178 days
Class
Class II
Product code
LOD
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K000943 (2001). 16 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2015: 1 descendant cleared2004: 1 descendant cleared2009: 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 clearedReference device: K021715 · Cemex RX, Cemex Isoplastic & Cemex XL · Exactech, Inc. · 2002K000943 · Cemex System Gun Application Version · Exactech, Inc. · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 4 descendants3 generations forward: 6 descendants4 generations forward: 3 descendants K000943 · Cemex System Gun Application Version · Exactech, Inc. · 20010
  1. Root · 1 generation backK000943 Cemex System Gun Application VersionExactech, Inc. · 2001
  2. This deviceK033596 Cemex Genta Bone Cement; Cemex Genta System Bone CementExactech, Inc. · 2004
  3. Descendant · cites it directly · 15 of its ownK043403 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 · cites it directly · 12 of its ownK143100 NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP…Cossington, Ltd. · 2015
  6. Descendant · 2 generations on · 9 of its ownK172906 REMEDY PLUS Hip Spacer, UNITE PLUS Bone CementOsteoremedies, LLC · 2018
  7. Descendant · 3 generations on · 4 of its ownK191981 REMEDY Acetabular CupOsteoremedies, LLC · 2019

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2004: 12009: 12015: 12018: 12019: 12020: 12021: 12023: 32024: 22025: 32026: 1
2004high 3 (2023) · low 0 (2005)2026

Most influential descendants

Showing 5 of 16 · See all
  • K043403Cemex System Genta Fast Bone CementExactech, Inc. · 2004 · cites it directly15descendants
  • 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 · cites it directly12descendants
  • K172906REMEDY PLUS Hip Spacer, UNITE PLUS Bone CementOsteoremedies, LLC · 2018 · 2 generations on9descendants
  • K191981REMEDY Acetabular CupOsteoremedies, LLC · 2019 · 3 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200910
201510
201810
201910
202010
202110
202330
202420
202530
202610
FIG. 1 — Lineage of K033596, 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
*K000943Cemex System Gun Application Version
Summary page 2
…mparison: Model Manufacturer 510(k) Number Cemex System Tecres, S.p.A. #K000943 INDICATIONS FOR USE Cemex Genta / Cemex Genta System bone cement is indicated for the fixation of prosth…
Exactech, Inc.2001—
†K021715Cemex RX, Cemex Isoplastic & Cemex XLExactech, Inc.2002—

Also cleared against K000943: 4 other devices →

What descends from it? (16)

See all 16

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K043403Cemex System Genta Fast Bone CementExactech, Inc.200415
K092773Cemex Genta, Genta System and Genta System FastTecres S.P.A.200914
K143100NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System GentaCossington, Ltd.201512

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?

  • Its one ancestor has no recall.
  • Of its descendants, K043403 (Exactech, Inc., 2004) has gone furthest, with 15 descendants of its own.
  • 4 other devices also cite its predicate K000943.

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 Genta / Cemex Genta System 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 K000943

4 other devices cite the same predicate.

  • K041105Macropore Hydrosorb Spine SystemMacropore Biosurgery, Inc. · 2004
  • K031430Cemex System FastExactech, Inc. · 2003
  • K021499Cemvac Ultra Pre-Packed with Depuy 1 Bone CementDePuy Orthopaedics, Inc. · 2002
  • K021715Cemex RX, Cemex Isoplastic & Cemex XLExactech, Inc. · 2002

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/K033596 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033596: Cemex Genta Bone Cement; Cemex Genta System Bone Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033596

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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