510(k) · Cleared
ClearedSmartset GMV 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 May 14, 2008 as substantially equivalent to K041656 (DePuy Orthopaedics, Inc., 2004) and 1 other predicate after a 20-day review. Its family tree reaches back 4 generations to 1984.
- Decided
- May 14, 2008
- Review
- 20 days
- Class
- Class II
- Product code
- MBB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to P810020 (1984). 8 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK081163 Smartset GMV Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2008
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) | K081163 | Smartset GMV Gentamicin Bone Cement | DePuy Orthopaedics, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K041656 | Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV Endurance Gentamicin…Summary page 1…(21 CFR 888.3027, Product Code MBB and LOD) Equivalent to: SmartSet GMV Endurance Gentamicin Bone Cement (K041656) SmartSet GHV Gentamicin Bone Cement (K033563) Device Description: Sm… | 2004 |
| * | K033563 | Smartset GHV Gentamicin Bone CementSummary page 1…artSet GMV Endurance Gentamicin Bone Cement (K041656) SmartSet GHV Gentamicin Bone Cement (K033563) Device Description: SmartSet GMV Gentamicin Bone Cement is a self-curing,… | 2004 |
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 24 years and passes through 2 companies; a new generation was cleared every 3.9 years on median.
- 3 of the 8 ancestors have a recall of any class.
- 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. 2008, this device’s year, is highlighted.
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?
SmartSet GMV 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/K081163 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081163: Smartset GMV 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/K081163
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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