510(k) · Cleared
ClearedSmartset MV 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 May 14, 2008 as substantially equivalent to P960001 (Depuy, Inc., 1997) and 1 other predicate after a 21-day review. Its family tree reaches back 2 generations to 1984. 1 later device descends from it.
- Decided
- May 14, 2008
- Review
- 21 days
- Class
- Class II
- Product code
- LOD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to P810020 (1984). 3 ancestors in all. 1 later device descends from it, 1 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 deviceK081155 Smartset MV Bone CementDePuy Orthopaedics, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK260536 Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CementDepuy Ireland UC · 2026
Most influential descendants
Showing 1 of 1 · See all- K260536Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CementDepuy Ireland UC · 2026 · cites it directly0descendants
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) | K081155 | Smartset MV Bone Cement | DePuy Orthopaedics, Inc. | 2008 | — |
| +1 | K260536 | Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement | Depuy Ireland UC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 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? (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 |
|---|---|---|---|
| * | P960001 | Depuy 1 Bone CementSummary page 1…n Name: Bone cement Classification Name: Bone cement (21 CFR 888.3027, Product Code LOD) Equivalent to: SmartSet MV Endurance Bone Cement (P960001, previously branded Endurance Bone Cement) SmartSet HV Bone Cement (K023012)… | 1997 |
| * | K023012 | Smartset HV Bone CementSummary page 1…SmartSet MV Endurance Bone Cement (P960001, previously branded Endurance Bone Cement) SmartSet HV Bone Cement (K023012) Device Description: SmartSet MV Bone Cement is a self-curing, radiopaque, polymethylmethacrylat… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260536 | Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement | 2026 | 0 |
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 19.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K260536 (Depuy Ireland UC, 2026) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate P960001.
How does its category compare?
All LOD devicesLOD Bone Cement: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 MV Bone Cement is indicated for the fixation of prostheses to living bone in orthopaedic musculoskeletal surgical procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, and revision of previous arthroplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081155 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081155: Smartset MV 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/K081155
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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