510(k) · Cleared

Cleared

Smartset GMV Endurance Gentamicin Bone Cement

K033382510(k) TraditionalCleared Feb 5, 2004105-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

DePuy Orthopaedics, Inc. · LOD Bone Cement

Cleared on Feb 5, 2004 as substantially equivalent to K023103 (DePuy Orthopaedics, Inc., 2003) and 2 other predicates after a 105-day review. Its family tree reaches back 1 generation to 1997. 16 later devices descend from it.

Decided: Feb 5, 2004
Review: 105 days
Class: Class II
Product code: LOD
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to P960001 (1997). 3 ancestors in all. 16 later devices descend from it, 7 citing it directly.

By dateBy generation

Root · 1 generation backP960001 Depuy 1 Bone CementDepuy, Inc. · 1997
This deviceK033382 Smartset GMV Endurance Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2004
Descendant · cites it directly · 8 of its ownK041656 Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV…DePuy Orthopaedics, Inc. · 2004
Descendant · cites it directly · 4 of its ownK053002 Depuy CMW 1 Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2005
Descendant · 2 generations on · 2 of its ownK173494 OrthoSteady G Bone CementG21, S.R.L. · 2018
Descendant · cites it directly · 2 of its ownK071927 Modification to Vertebroplastic Radiopaque Bone CementDepuy Spine, A Johnson & Johnson Company · 2007
Descendant · cites it directly · 2 of its ownK053003 Depuy CMW 1, 2 and 3 Bone CementsDePuy Orthopaedics, Inc. · 2005

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2004high 3 (2007) · low 0 (2009)2026

Most influential descendants

Showing 5 of 16 · See all

K041656Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV Endurance Gentamicin…DePuy Orthopaedics, Inc. · 2004 · cites it directly8descendants
K053002Depuy CMW 1 Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2005 · cites it directly4descendants
K173494OrthoSteady G Bone CementG21, S.R.L. · 2018 · 2 generations on2descendants
K071927Modification to Vertebroplastic Radiopaque Bone CementDepuy Spine, A Johnson & Johnson Company · 2007 · cites it directly2descendants
K053003Depuy CMW 1, 2 and 3 Bone CementsDePuy Orthopaedics, Inc. · 2005 · cites it directly2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	P960001	Depuy 1 Bone Cement	Depuy, Inc.	1997	—
0 (this device)	K033382	Smartset GMV Endurance Gentamicin Bone Cement	DePuy Orthopaedics, Inc.	2004	—
+1	K041656	Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV Endurance…	DePuy Orthopaedics, Inc.	2004	—
+1	K053002	Depuy CMW 1 Gentamicin Bone Cement	DePuy Orthopaedics, Inc.	2005	—
+2	K173494	OrthoSteady G Bone Cement	G21, S.R.L.	2018	—
+1	K071927	Modification to Vertebroplastic Radiopaque Bone Cement	Depuy Spine, A Johnson & Johnson Company	2007	—
+1	K053003	Depuy CMW 1, 2 and 3 Bone Cements	DePuy Orthopaedics, Inc.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	2	0
2005	2	0
2006	2	0
2007	3	0
2008	1	0
2011	1	0
2018	1	0
2020	3	0
2022	1	0

FIG. 1 — Lineage of K033382, 1997–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (3)

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	Applicant	Decided	Recalls
*	K023103	Depuy 1 Gentamicin Bone Cement Summary page 1 …e, design, materials, sterilization and packaging to DePuv 1 Gentamicin Bone Cement (K023103), Simplex P with Tobramycin Bone Cement (K014199…	DePuy Orthopaedics, Inc.	2003	—
*	K014199	Surgical Simplex P with Tobramycin Summary page 1 …o DePuv 1 Gentamicin Bone Cement (K023103), Simplex P with Tobramycin Bone Cement (K014199) and Endurance Bone Cement (P960001/S003). Endurance Bone…	Howmedica Osteonics Corp.	2003	2
*	P960001	Depuy 1 Bone Cement Summary page 1 …23103), Simplex P with Tobramycin Bone Cement (K014199) and Endurance Bone Cement (P960001/S003). Endurance Bone Cement was down classified…	Depuy, Inc.	1997	—

Also cleared against K023103: 3 other devices →

What descends from it? (16)

See all 16

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

Number	Device	Applicant	Decided	Descendants
K041656	Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV Endurance Gentamicin…	DePuy Orthopaedics, Inc.	2004	8
K053002	Depuy CMW 1 Gentamicin Bone Cement	DePuy Orthopaedics, Inc.	2005	4
K071927	Modification to Vertebroplastic Radiopaque Bone Cement	Depuy Spine, A Johnson & Johnson Company	2007	2
K053003	Depuy CMW 1, 2 and 3 Bone Cements	DePuy Orthopaedics, Inc.	2005	2
K042591	Smartmix Pre-Filled Mixing System	DePuy Orthopaedics, Inc.	2004	1
K071791	Modification to Cranioplastic, Model 43-1280	Codman & Shurtleff, Inc.	2007	0
K071776	Aneuroplastic, Model 43-1290	Codman & Shurtleff, Inc.	2007	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?

1 of the 3 ancestors has a recall of any class.
Of its descendants, K041656 (DePuy Orthopaedics, Inc., 2004) has gone furthest, with 8 descendants of its own.
3 other devices also cite its predicate K023103.

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	—

What is it indicated for?

Smartset GMV Endurance Gentamicin Bone Cement is indicated for use 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/K033382 · printed Nov 3, 2026

Cite this page

510(k) Report. “K033382: Smartset GMV Endurance Gentamicin Bone Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033382

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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