510(k) · Cleared
Recalled · Class II · 2015Smartset GHV Gentamicin Bone Cement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · LOD Bone Cement
Cleared on Feb 5, 2004 as substantially equivalent to K023012 (DePuy Orthopaedics, Inc., 2003) and 2 other predicates after an 85-day review. Its family tree reaches back 2 generations to 1984. 9 later devices descend from it. It has been recalled once.
- Decided
- Feb 5, 2004
- Review
- 85 days
- Class
- Class II
- Product code
- LOD
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to P810020 (1984). 5 ancestors in all. 9 later devices descend from it, 4 citing it directly.
- Root · 2 generations backP810020 Palacos R Bone CementSmith & Nephew Richards, Inc. · 1984 · Recalled
- 1 generation backK023012 Smartset HV Bone CementDePuy Orthopaedics, Inc. · 2003
- This deviceK033563 Smartset GHV Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2004
- Descendant · cites it directly · 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
- Descendant · 3 generations on · 2 of its ownK173494 OrthoSteady G Bone CementG21, S.R.L. · 2018
- Descendant · 2 generations on · 1 of its ownK042591 Smartmix Pre-Filled Mixing SystemDePuy Orthopaedics, Inc. · 2004
- Descendant · 4 generations on · 0 of its ownK193061 G3 40 Radiopaque Bone CementG21, S.R.L. · 2020
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- 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
- K042591Smartmix Pre-Filled Mixing SystemDePuy Orthopaedics, Inc. · 2004 · 2 generations on1descendant
- K193061G3 40 Radiopaque Bone CementG21, S.R.L. · 2020 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P810020 | Palacos R Bone Cement | Smith & Nephew Richards, Inc. | 1984 | 1 |
| −1 | K023012 | Smartset HV Bone Cement | DePuy Orthopaedics, Inc. | 2003 | — |
| 0 (this device) | K033563 | Smartset GHV Gentamicin Bone Cement | DePuy Orthopaedics, Inc. | 2004 | — |
| +1 | 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 | — |
| +3 | K173494 | OrthoSteady G Bone Cement | G21, S.R.L. | 2018 | — |
| +2 | K042591 | Smartmix Pre-Filled Mixing System | DePuy Orthopaedics, Inc. | 2004 | — |
| +4 | K193061 | G3 40 Radiopaque Bone Cement | G21, S.R.L. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 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 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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K023012 | Smartset HV Bone CementSummary page 2…ence of SmartSet GHV Gentamicin Bone Cement is demonstrated by its similarity in design, materials, sterilization and packaging to SmartSet HV Bone Cement (1(023012) and its similarity in indications for use to DePuy 1 Gentamicin (K023103) and Simplex P with Tobramycin (K014199) Bone Cem… | 2003 |
| * | K023103 | Depuy 1 Gentamicin Bone CementSummary page 2…similarity in design, materials, sterilization and packaging to SmartSet HV Bone Cement (1(023012) and its similarity in indications for use to DePuy 1 Gentamicin (K023103) and Simplex P with Tobramycin (K014199) Bone Cements. The determination of substantial equivalence for this device… | 2003 |
| * | K014199 | Surgical Simplex P with TobramycinSummary page 2…and packaging to SmartSet HV Bone Cement (1(023012) and its similarity in indications for use to DePuy 1 Gentamicin (K023103) and Simplex P with Tobramycin (K014199) Bone Cements. The determination of substantial equivalence for this device was based on a detailed device descripti… | 2003 |
What descends from it? (9)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 11, 2015 | Class II | Z-1246-2015 | Under Investigation by firm | One lot of SMARTSET GHV Gentamicin Bone Cement is partially agglomerated . This may result in surgical delays while a replacement package of cement is retrieved and mixed. |
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 19.0 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K041656 (DePuy Orthopaedics, Inc., 2004) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K023012.
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 | — |
What is it indicated for?
SmartSet GHV 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/K033563 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033563: Smartset GHV 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/K033563
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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