510(k) · Cleared
ClearedDepuy CMW 1 Gentamicin Bone Cement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · MBB Bone Cement, Antibiotic
Cleared on Nov 22, 2005 as substantially equivalent to K041656 (DePuy Orthopaedics, Inc., 2004) and 1 other predicate after a 27-day review. Its family tree reaches back 4 generations to 1984. 4 later devices descend from it.
- Decided
- Nov 22, 2005
- Review
- 27 days
- Class
- Class II
- Product code
- MBB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to P810020 (1984). 8 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 4 generations backP810020 Palacos R Bone CementSmith & Nephew Richards, Inc. · 1984 · Recalled
- 3 generations backK023012 Smartset HV Bone CementDePuy Orthopaedics, Inc. · 2003
- 2 generations backK033563 Smartset GHV Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2004 · Recalled
- 1 generation backK041656 Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV…DePuy Orthopaedics, Inc. · 2004
- This deviceK053002 Depuy CMW 1 Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK173494 OrthoSteady G Bone CementG21, S.R.L. · 2018
- Descendant · 2 generations on · 0 of its ownK193061 G3 40 Radiopaque Bone CementG21, S.R.L. · 2020
- Descendant · 2 generations on · 0 of its ownK193059 G1 40 Radiopaque Bone CementG21, S.R.L. · 2020
- Descendant · cites it directly · 0 of its ownK061144 Depuy CMW 2 and CMW 3 Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2006
Most influential descendants
Showing 4 of 4 · See all- K173494OrthoSteady G Bone CementG21, S.R.L. · 2018 · cites it directly2descendants
- K193061G3 40 Radiopaque Bone CementG21, S.R.L. · 2020 · 2 generations on0descendants
- K193059G1 40 Radiopaque Bone CementG21, S.R.L. · 2020 · 2 generations on0descendants
- K061144Depuy CMW 2 and CMW 3 Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | P810020 | Palacos R Bone Cement | Smith & Nephew Richards, Inc. | 1984 | 1 |
| −3 | K023012 | Smartset HV Bone Cement | DePuy Orthopaedics, Inc. | 2003 | — |
| −2 | K033563 | Smartset GHV Gentamicin Bone Cement | DePuy Orthopaedics, Inc. | 2004 | 1 |
| −1 | K041656 | Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV Endurance… | DePuy Orthopaedics, Inc. | 2004 | — |
| 0 (this device) | K053002 | Depuy CMW 1 Gentamicin Bone Cement | DePuy Orthopaedics, Inc. | 2005 | — |
| +1 | K173494 | OrthoSteady G Bone Cement | G21, S.R.L. | 2018 | — |
| +2 | K193061 | G3 40 Radiopaque Bone Cement | G21, S.R.L. | 2020 | — |
| +2 | K193059 | G1 40 Radiopaque Bone Cement | G21, S.R.L. | 2020 | — |
| +1 | K061144 | Depuy CMW 2 and CMW 3 Gentamicin Bone Cement | DePuy Orthopaedics, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
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 K252443 SpaceFix Shoulder Spacerscore 12.4 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K041656 | Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV Endurance Gentamicin…Summary page 1…1l; 21 CFR 888.3027 DEVICE PRODUCT CODE: MBB SUBSTANTIALLY EQUIVALENT DEVICES: DePuy I Gentamicin Bone Cement (K041656) (now branded DePuy CMW I Gentamicin Bone Cement).… | 2004 |
| * | K033382 | Smartset GMV Endurance Gentamicin Bone CementSummary page 1…ePuy CMW I Gentamicin Bone Cement). SmartSet GMV Endurance Gentamicin Bone Cement (K033382). SmartSet MV Endurance Bone cement (P960001/SI)… | 2004 |
| Kept off the family tree | P960001/ | SmartSet MV Endurance Bone Cement Number could not be read |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 21 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 3 of the 8 ancestors have a recall of any class.
- Of its descendants, K173494 (G21, S.R.L., 2018) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K041656.
How does its category compare?
All MBB devicesMBB Bone Cement, Antibiotic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MBB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBB
106in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBB
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBB
172in 2025
MAUDE reports naming product code MBB, 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 | 1 | — | 0 | 1 |
| 2008 | 1 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 9 |
| 2010 | 0 | — | 0 | 18 |
| 2011 | 0 | — | 0 | 31 |
| 2012 | 0 | — | 0 | 34 |
| 2013 | 0 | — | 2 | 32 |
| 2014 | 1 | — | 0 | 41 |
| 2015 | 1 | — | 0 | 20 |
| 2016 | 2 | — | 0 | 327 |
| 2017 | 1 | — | 0 | 288 |
| 2018 | 0 | — | 0 | 332 |
| 2019 | 2 | — | 0 | 497 |
| 2020 | 1 | — | 0 | 375 |
| 2021 | 1 | — | 0 | 649 |
| 2022 | 3 | 106 | 1 | 275 |
| 2023 | 0 | — | 0 | 262 |
| 2024 | 2 | — | 0 | 212 |
| 2025 | 1 | — | 0 | 172 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
DePuy CMW 1 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/K053002 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053002: Depuy CMW 1 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/K053002
Report an extraction error
Are you the manufacturer?
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