510(k) Report

510(k) · Cleared

Cleared

Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV Endurance Gentamicin Bone Cement

K041656510(k) SpecialCleared Jul 1, 200413-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 Jul 1, 2004 as substantially equivalent to K023103 (DePuy Orthopaedics, Inc., 2003) and 2 other predicates after a 13-day review. Its family tree reaches back 3 generations to 1984. 8 later devices descend from it.

Decided
Jul 1, 2004
Review
13 days
Class
Class II
Product code
LOD
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to P810020 (1984). 7 ancestors in all. 8 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2003: 2 other ancestors1997: 1 other ancestor2008: 1 descendant cleared2006: 2 descendants cleared2004: 1 descendant cleared2005: 1 descendant cleared2018: 1 descendant cleared2020: 2 descendants clearedP810020 · Palacos R Bone Cement · Smith & Nephew Richards, Inc. · 1984 · recalledK023012 · Smartset HV Bone Cement · DePuy Orthopaedics, Inc. · 2003K033563 · Smartset GHV Gentamicin Bone Cement · DePuy Orthopaedics, Inc. · 2004 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors 1 generation forward: 4 descendants2 generations forward: 2 descendants3 generations forward: 2 descendants K033563 · Smartset GHV Gentamicin Bone Cement · DePuy Orthopaedics, Inc. · 2004 · recalledK023012 · Smartset HV Bone Cement · DePuy Orthopaedics, Inc. · 2003P810020 · Palacos R Bone Cement · Smith & Nephew Richards, Inc. · 1984 · recalled0
  1. Root · 3 generations backP810020 Palacos R Bone CementSmith & Nephew Richards, Inc. · 1984 · Recalled
  2. 2 generations backK023012 Smartset HV Bone CementDePuy Orthopaedics, Inc. · 2003
  3. 1 generation backK033563 Smartset GHV Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2004 · Recalled
  4. This deviceK041656 Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV…DePuy Orthopaedics, Inc. · 2004
  5. Descendant · cites it directly · 4 of its ownK053002 Depuy CMW 1 Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2005
  6. Descendant · 2 generations on · 2 of its ownK173494 OrthoSteady G Bone CementG21, S.R.L. · 2018
  7. Descendant · cites it directly · 1 of its ownK042591 Smartmix Pre-Filled Mixing SystemDePuy Orthopaedics, Inc. · 2004
  8. Descendant · 3 generations on · 0 of its ownK193061 G3 40 Radiopaque Bone CementG21, S.R.L. · 2020
  9. Descendant · 3 generations on · 0 of its ownK193059 G1 40 Radiopaque Bone CementG21, S.R.L. · 2020

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2004: 12005: 12006: 22008: 12018: 12020: 2
2004high 2 (2006) · low 0 (2007)2026

Most influential descendants

Showing 5 of 8 · See all
  • K053002Depuy CMW 1 Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2005 · cites it directly4descendants
  • K173494OrthoSteady G Bone CementG21, S.R.L. · 2018 · 2 generations on2descendants
  • K042591Smartmix Pre-Filled Mixing SystemDePuy Orthopaedics, Inc. · 2004 · cites it directly1descendant
  • K193061G3 40 Radiopaque Bone CementG21, S.R.L. · 2020 · 3 generations on0descendants
  • K193059G1 40 Radiopaque Bone CementG21, S.R.L. · 2020 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3P810020Palacos R Bone CementSmith & Nephew Richards, Inc.19841
−2K023012Smartset HV Bone CementDePuy Orthopaedics, Inc.2003—
−1K033563Smartset GHV Gentamicin Bone CementDePuy Orthopaedics, Inc.20041
0 (this device)K041656Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV Endurance…DePuy Orthopaedics, Inc.2004—
+1K053002Depuy CMW 1 Gentamicin Bone CementDePuy Orthopaedics, Inc.2005—
+2K173494OrthoSteady G Bone CementG21, S.R.L.2018—
+1K042591Smartmix Pre-Filled Mixing SystemDePuy Orthopaedics, Inc.2004—
+3K193061G3 40 Radiopaque Bone CementG21, S.R.L.2020—
+3K193059G1 40 Radiopaque Bone CementG21, S.R.L.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200320
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
200620
200810
201810
202020
FIG. 1 — Lineage of K041656, 1984–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K023103Depuy 1 Gentamicin Bone Cement
Summary page 1
…21 CFR 888.3027 DEVICE PRODUCT CODE: LOD SUBSTANTIALLY EQUIVALENT DEVICE: DePuy I Gentamicin Bone Cement (K023103), SmartSet GMV Endurance Gentamicin Bone Cement (K033382) and SmartSet…
DePuy Orthopaedics, Inc.2003—
*K033382Smartset GMV Endurance Gentamicin Bone Cement
Summary page 1
…DePuy I Gentamicin Bone Cement (K023103), SmartSet GMV Endurance Gentamicin Bone Cement (K033382) and SmartSet GHV Gentamicin Bone Cement (K033563) DEVICE DESCRIPTION: DePuy I Gent…
DePuy Orthopaedics, Inc.2004—
*K033563Smartset GHV Gentamicin Bone Cement
Summary page 1
…Endurance Gentamicin Bone Cement (K033382) and SmartSet GHV Gentamicin Bone Cement (K033563) DEVICE DESCRIPTION: DePuy I Gentamicin and SmartSet GMV Endurance Gentamicin Bone Cements arc self-curing cements, containing o…
DePuy Orthopaedics, Inc.20041

Also cleared against K023103: 3 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K053002Depuy CMW 1 Gentamicin Bone CementDePuy Orthopaedics, Inc.20054
K042591Smartmix Pre-Filled Mixing SystemDePuy Orthopaedics, Inc.20041
K081163Smartset GMV Gentamicin Bone CementDePuy Orthopaedics, Inc.20080
K061144Depuy CMW 2 and CMW 3 Gentamicin Bone CementDePuy Orthopaedics, Inc.20060

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 20 years and passes through 2 companies; a new generation was cleared every 12 months on median.
  • 3 of the 7 ancestors have a recall of any class.
  • Of its descendants, K053002 (DePuy Orthopaedics, Inc., 2005) has gone furthest, with 4 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

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?

DePuy I Gentamicin Bone Cement and SmartSet GMV Endurance Gentamicin Bone Cement are 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.

Also cleared against K023103

3 other devices cite the same predicate.

  • K211869OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cementOrmed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE · 2022
  • K033382Smartset GMV Endurance Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2004
  • K033563Smartset GHV Gentamicin Bone CementDePuy Orthopaedics, Inc. · 20041 recall

More from DePuy Orthopaedics, Inc.

361 FDA decisions under this applicant name. See the company

  • P070026/S129Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S130CERAMAX Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S128CERAMAX® Ceramic Total Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S127Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • K252887DePuy ATTUNE™ Knee SystemDePuy Orthopaedics, Inc. · 2026

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/K041656 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041656: Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV Endurance Gentamicin 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/K041656

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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