510(k) Report

510(k) · Cleared

Cleared

Depuy 1 Gentamicin Bone Cement

K023103510(k) TraditionalCleared Sep 29, 2003376-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 Sep 29, 2003 after a 376-day review. The FDA summary names its predicate without a number. 19 later devices descend from it.

Decided
Sep 29, 2003
Review
376 days
Class
Class II
Product code
LOD
Recalls
None
Predicates
0

19 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2022: 2 descendants cleared2004: 4 descendants cleared2007: 3 descendants cleared2005: 2 descendants cleared2008: 1 descendant cleared2006: 2 descendants cleared2018: 1 descendant cleared2020: 3 descendants cleared2011: 1 descendant cleared200020052010201520202025
  1. This deviceK023103 Depuy 1 Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2003
  2. Descendant · cites it directly · 16 of its ownK033382 Smartset GMV Endurance Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2004
  3. Descendant · cites it directly · 9 of its ownK033563 Smartset GHV Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2004 · Recalled
  4. Descendant · cites it directly · 8 of its ownK041656 Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV…DePuy Orthopaedics, Inc. · 2004
  5. Descendant · 2 generations on · 4 of its ownK053002 Depuy CMW 1 Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2005
  6. Descendant · 3 generations on · 2 of its ownK173494 OrthoSteady G Bone CementG21, S.R.L. · 2018

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2004: 42005: 22006: 22007: 32008: 12011: 12018: 12020: 32022: 2
2004high 4 (2004) · low 0 (2009)2026

Most influential descendants

Showing 5 of 19 · See all
  • K033382Smartset GMV Endurance Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2004 · cites it directly16descendants
  • K033563Smartset GHV Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2004 · cites it directly9descendants
  • 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 · 2 generations on4descendants
  • K173494OrthoSteady G Bone CementG21, S.R.L. · 2018 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K023103Depuy 1 Gentamicin Bone CementDePuy Orthopaedics, Inc.2003—
+1K033382Smartset GMV Endurance Gentamicin Bone CementDePuy Orthopaedics, Inc.2004—
+1K033563Smartset GHV Gentamicin Bone CementDePuy Orthopaedics, Inc.20041
+1K041656Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV Endurance…DePuy Orthopaedics, Inc.2004—
+2K053002Depuy CMW 1 Gentamicin Bone CementDePuy Orthopaedics, Inc.2005—
+3K173494OrthoSteady G Bone CementG21, S.R.L.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200440
200520
200620
200730
200810
201110
201810
202030
202220
FIG. 1 — Lineage of K023103, 2003–2022Source: 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? (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
*—DePuy 1 Bone Cement
Named without a submission number
—
*—BACTISEAL Catheter (Codman)
Named without a submission number
—
*—OrthoGuard AB Antimicrobial Sleeve (Smith and Nephew)
Named without a submission number
—

What descends from it? (19)

See all 19

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

NumberDeviceApplicantDecidedDescendants
K033382Smartset GMV Endurance Gentamicin Bone CementDePuy Orthopaedics, Inc.200416
K033563Smartset GHV Gentamicin Bone CementDePuy Orthopaedics, Inc.20049
K041656Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV Endurance Gentamicin…DePuy Orthopaedics, Inc.20048
K211869OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA)…Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE20220

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, K033382 (DePuy Orthopaedics, 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

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 1 Gentamicin 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.

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/K023103 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023103: Depuy 1 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/K023103

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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