510(k) Report

510(k) · Cleared

Cleared

Depuy CMW 2 and CMW 3 Gentamicin Bone Cement

K061144510(k) TraditionalCleared Jun 8, 200644-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. · MBB Bone Cement, Antibiotic

Cleared on Jun 8, 2006 as substantially equivalent to K053002 (DePuy Orthopaedics, Inc., 2005) and 3 other predicates after a 44-day review. Its family tree reaches back 5 generations to 1984.

Decided
Jun 8, 2006
Review
44 days
Class
Class II
Product code
MBB
Recalls
None
Predicates
4

Its longest line of descent runs back 5 generations to P810020 (1984). 10 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 1 other ancestor2004: 1 other ancestor2003: 2 other ancestors1997: 1 other ancestorP810020 · 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 · recalledK041656 · Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV Endurance Gentamicin Bone Cement · DePuy Orthopaedics, Inc. · 2004K053002 · Depuy CMW 1 Gentamicin Bone Cement · DePuy Orthopaedics, Inc. · 2005198019851990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 4 other ancestors K053002 · Depuy CMW 1 Gentamicin Bone Cement · DePuy Orthopaedics, Inc. · 2005K041656 · Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV Endurance Gentamicin Bone Cement · DePuy Orthopaedics, Inc. · 2004K033563 · 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 · recalled−50
  1. Root · 5 generations backP810020 Palacos R Bone CementSmith & Nephew Richards, Inc. · 1984 · Recalled
  2. 4 generations backK023012 Smartset HV Bone CementDePuy Orthopaedics, Inc. · 2003
  3. 3 generations backK033563 Smartset GHV Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2004 · Recalled
  4. 2 generations backK041656 Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV…DePuy Orthopaedics, Inc. · 2004
  5. 1 generation backK053002 Depuy CMW 1 Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2005
  6. This deviceK061144 Depuy CMW 2 and CMW 3 Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5P810020Palacos R Bone CementSmith & Nephew Richards, Inc.19841
−4K023012Smartset HV Bone CementDePuy Orthopaedics, Inc.2003—
−3K033563Smartset GHV Gentamicin Bone CementDePuy Orthopaedics, Inc.20041
−2K041656Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV Endurance…DePuy Orthopaedics, Inc.2004—
−1K053002Depuy CMW 1 Gentamicin Bone CementDePuy Orthopaedics, Inc.2005—
0 (this device)K061144Depuy CMW 2 and CMW 3 Gentamicin Bone CementDePuy Orthopaedics, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200320
200410
200510
FIG. 1 — Lineage of K061144, 1984–2006Source: 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 MBB? 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 MBB device

  1. #1 K252443 SpaceFix Shoulder Spacerscore 12.4 · 9 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? (4)

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
*K053002Depuy CMW 1 Gentamicin Bone Cement
Summary page 1
…DePuy Orthopaedics Inc. Tel.: (574) 267-8143 Fax: (574) 371-4987 Equivalent to: DePuy CMW I Gentamicin Bone Cement (K053002) SmartSet GMV Endurance Gentamicin Bone Cement (K041656). SmartSet GHV Gentamicin B…
DePuy Orthopaedics, Inc.2005—
*K041656Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV Endurance Gentamicin…
Summary page 1
…Fax: (574) 371-4987 Equivalent to: DePuy CMW I Gentamicin Bone Cement (K053002) SmartSet GMV Endurance Gentamicin Bone Cement (K041656). SmartSet GHV Gentamicin Bone Cement (K033563). DePuy CMW 2 Bone Cement (K053003)…
DePuy Orthopaedics, Inc.2004—
*K033563Smartset GHV Gentamicin Bone Cement
Summary page 1
…tamicin Bone Cement (K053002) SmartSet GMV Endurance Gentamicin Bone Cement (K041656). SmartSet GHV Gentamicin Bone Cement (K033563). DePuy CMW 2 Bone Cement (K053003) DePuy CMW 3 Bone Cement (K053003) Device Desc…
DePuy Orthopaedics, Inc.20041
*K053003Depuy CMW 1, 2 and 3 Bone Cements
Summary page 1
…Set GMV Endurance Gentamicin Bone Cement (K041656). SmartSet GHV Gentamicin Bone Cement (K033563). DePuy CMW 2 Bone Cement (K053003) DePuy CMW 3 Bone Cement (K053003) Device Description: DePuy CMW 2 Gentamicin Bone Cement and DePuy CM…
DePuy Orthopaedics, Inc.2005—

Also cleared against K053002: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 22 years and passes through 2 companies; a new generation was cleared every 12 months on median.
  • 3 of the 10 ancestors have a recall of any class.
  • 1 other device also cites its predicate K053002.

How does its category compare?

All MBB devices

MBB Bone Cement, Antibiotic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MBB

1in 2025

2007: 12008: 12014: 12015: 12016: 22017: 12019: 22020: 12021: 12022: 32024: 22025: 1
2007high 3 (2022) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBB

106in 2022

2022: 106 days median
2007high 106 (2022)2026

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

Recalls per year · MBB

1in 2022

2013: 22022: 12026 (partial year): 2
2007high 2 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MBB

172in 2025

2007: 12008: 32009: 92010: 182011: 312012: 342013: 322014: 412015: 202016: 3272017: 2882018: 3322019: 4972020: 3752021: 6492022: 2752023: 2622024: 2122025: 172
2007high 649 (2021) · low 1 (2007)2025

MAUDE reports naming product code MBB, 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
20071—01
20081—03
20090—09
20100—018
20110—031
20120—034
20130—232
20141—041
20151—020
20162—0327
20171—0288
20180—0332
20192—0497
20201—0375
20211—0649
202231061275
20230—0262
20242—0212
20251—0172
20260—2—

What is it 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 K053002

1 other device cites the same predicate.

  • K173494OrthoSteady G Bone CementG21, S.R.L. · 2018

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 MBB

The MBB category page

  • K252443SpaceFix Shoulder SpacerG21, S.R.L. · 2025
  • K242216Gentafix® (1, 3, 3MV)Teknimed Sas · 2024
  • K240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsOsartis GmbH · 2024
  • K222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc. · 2022
  • K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc. · 2022

https://510kreport.com/device/K061144 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061144: Depuy CMW 2 and CMW 3 Gentamicin Bone Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061144

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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