PMA · Approved
ApprovedDepuy 1 Bone Cement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy, Inc. · LOD Bone Cement
Approved on Feb 11, 1997 through premarket approval, which rests on the device’s own clinical evidence after a 397-day review. 22 later devices descend from it.
- Decided
- Feb 11, 1997
- Review
- 397 days
- Class
- Class II
- Product code
- LOD
- Recalls
- None
22 later devices descend from it, 6 citing it directly.
- This deviceP960001 Depuy 1 Bone CementDepuy, Inc. · 1997
- Descendant · cites it directly · 16 of its ownK033382 Smartset GMV Endurance Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2004
- Descendant · cites it directly · 12 of its ownK023012 Smartset HV Bone CementDePuy Orthopaedics, Inc. · 2003
- Descendant · 2 generations on · 9 of its ownK033563 Smartset GHV Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 8 of its ownK041656 Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV…DePuy Orthopaedics, Inc. · 2004
- Descendant · 2 generations on · 4 of its ownK053002 Depuy CMW 1 Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2005
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K033382Smartset GMV Endurance Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2004 · cites it directly16descendants
- K023012Smartset HV Bone CementDePuy Orthopaedics, Inc. · 2003 · cites it directly12descendants
- K033563Smartset GHV Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2004 · 2 generations on9descendants
- K041656Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV Endurance Gentamicin…DePuy Orthopaedics, Inc. · 2004 · 2 generations on8descendants
- K053002Depuy CMW 1 Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2005 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P960001 | Depuy 1 Bone Cement | Depuy, Inc. | 1997 | — |
| +1 | K033382 | Smartset GMV Endurance Gentamicin Bone Cement | DePuy Orthopaedics, Inc. | 2004 | — |
| +1 | K023012 | Smartset HV Bone Cement | DePuy Orthopaedics, Inc. | 2003 | — |
| +2 | K033563 | Smartset GHV Gentamicin Bone Cement | DePuy Orthopaedics, Inc. | 2004 | 1 |
| +2 | K041656 | Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV Endurance… | DePuy Orthopaedics, Inc. | 2004 | — |
| +2 | K053002 | Depuy CMW 1 Gentamicin Bone Cement | DePuy Orthopaedics, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2022 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA PMA database (decision fields and supplements), 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
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (22)
See all 226 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033382 | Smartset GMV Endurance Gentamicin Bone Cement | 2004 | 16 |
| K023012 | Smartset HV Bone Cement | 2003 | 12 |
| K053003 | Depuy CMW 1, 2 and 3 Bone Cements | 2005 | 2 |
| K021499 | Cemvac Ultra Pre-Packed with Depuy 1 Bone Cement | 2002 | 2 |
| K081155 | Smartset MV Bone Cement | 2008 | 1 |
| K042591 | Smartmix Pre-Filled Mixing System | 2004 | 1 |
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 devicesLOD Bone Cement: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LOD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LOD
277in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LOD
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LOD
355in 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 | — |
https://510kreport.com/device/P960001 · printed Nov 6, 2026
Cite this page
510(k) Report. “P960001: Depuy 1 Bone Cement.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P960001
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026