510(k) · Cleared

Cleared

Cemex System Gun Application Version

K000943510(k) TraditionalCleared Feb 8, 2001322-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

Cleared on Feb 8, 2001 after a 322-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 29 later devices descend from it.

Decided: Feb 8, 2001
Review: 322 days
Class: Class II
Product code: LOD
Recalls: None
Predicates: 0

29 later devices descend from it, 5 citing it directly.

This deviceK000943 Cemex System Gun Application VersionExactech, Inc. · 2001
Descendant · cites it directly · 16 of its ownK033596 Cemex Genta Bone Cement; Cemex Genta System Bone CementExactech, Inc. · 2004
Descendant · 2 generations on · 15 of its ownK043403 Cemex System Genta Fast Bone CementExactech, Inc. · 2004
Descendant · 2 generations on · 14 of its ownK092773 Cemex Genta, Genta System and Genta System FastTecres S.P.A. · 2009
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
Descendant · 3 generations on · 9 of its ownK172906 REMEDY PLUS Hip Spacer, UNITE PLUS Bone CementOsteoremedies, LLC · 2018

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

2002high 4 (2004) · low 0 (2007)2026

Most influential descendants

Showing 5 of 29 · See all

K033596Cemex Genta Bone Cement; Cemex Genta System Bone CementExactech, Inc. · 2004 · cites it directly16descendants
K043403Cemex System Genta Fast Bone CementExactech, Inc. · 2004 · 2 generations on15descendants
K092773Cemex Genta, Genta System and Genta System FastTecres S.P.A. · 2009 · 2 generations on14descendants
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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K000943	Cemex System Gun Application Version	Exactech, Inc.	2001	—
+1	K033596	Cemex Genta Bone Cement; Cemex Genta System Bone Cement	Exactech, Inc.	2004	—
+2	K043403	Cemex System Genta Fast Bone Cement	Exactech, Inc.	2004	—
+2	K092773	Cemex Genta, Genta System and Genta System Fast	Tecres S.P.A.	2009	—
+2	K143100	NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV…	Cossington, Ltd.	2015	—
+3	K172906	REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement	Osteoremedies, LLC	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0
2003	1	0
2004	4	0
2005	1	0
2006	1	0
2008	1	0
2009	2	0
2015	3	0
2018	1	0
2019	1	0
2020	1	0
2021	2	0
2023	3	0
2024	2	0
2025	3	0
2026	1	0

FIG. 1 — Lineage of K000943, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (29)

See all 29

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

Number	Device	Applicant	Decided	Descendants
K033596	Cemex Genta Bone Cement; Cemex Genta System Bone Cement	Exactech, Inc.	2004	16
K041105	Macropore Hydrosorb Spine System	Macropore Biosurgery, Inc.	2004	4
K021715	Cemex RX, Cemex Isoplastic & Cemex XL	Exactech, Inc.	2002	3
K021499	Cemvac Ultra Pre-Packed with Depuy 1 Bone Cement	DePuy Orthopaedics, Inc.	2002	2
K031430	Cemex System Fast	Exactech, Inc.	2003	0

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?

Of its descendants, K033596 (Exactech, Inc., 2004) has gone furthest, with 16 descendants of its own.

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

2007high 4 (2015) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LOD

277in 2022

2007high 277 (2022) · low 90 (2019)2026

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

Recalls per year · LOD

2in 2022

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

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

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	—

https://510kreport.com/device/K000943 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000943: Cemex System Gun Application Version.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000943

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026