510(k) · Cleared
ClearedSmartmix Pre-Filled Mixing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · KIH Dispenser, Cement
Cleared on Oct 22, 2004 as substantially equivalent to P960001 (Depuy, Inc., 1997) and 3 other predicates after a 29-day review. Its family tree reaches back 4 generations to 1984. 1 later device descends from it.
- Decided
- Oct 22, 2004
- Review
- 29 days
- Class
- Class I
- Product code
- KIH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to P810020 (1984). 11 ancestors in all. 1 later device descends from it, 1 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 deviceK042591 Smartmix Pre-Filled Mixing SystemDePuy Orthopaedics, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK053445 Smartmix Cemvac Pre-Filled with Smartset HV Bone CementDePuy Orthopaedics, Inc. · 2006
Most influential descendants
Showing 1 of 1 · See all- K053445Smartmix Cemvac Pre-Filled with Smartset HV 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) | K042591 | Smartmix Pre-Filled Mixing System | DePuy Orthopaedics, Inc. | 2004 | — |
| +1 | K053445 | Smartmix Cemvac Pre-Filled with Smartset HV Bone Cement | DePuy Orthopaedics, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 KIH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
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…CFR 888.3027 DEVICE CODE: KIH pre-filled with LOD JDZ pre-filled with LOD SUBSTANTIALLY EQUIVALENT DEVICES: Endurance Bone Cement: P960001 Supplement I SmartSet GMV Endurance Gentamicin Bone Cement: K033382 and K041656… | 1997 |
| * | K033382 | Smartset GMV Endurance Gentamicin Bone CementSummary page 1…JDZ pre-filled with LOD SUBSTANTIALLY EQUIVALENT DEVICES: Endurance Bone Cement: P960001 Supplement I SmartSet GMV Endurance Gentamicin Bone Cement: K033382 and K041656 Cemvac Ultra pre-packed with DePuy I Bone Cement: K021499… | 2004 |
| * | K041656 | Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV Endurance Gentamicin…Summary page 1…TIALLY EQUIVALENT DEVICES: Endurance Bone Cement: P960001 Supplement I SmartSet GMV Endurance Gentamicin Bone Cement: K033382 and K041656 Cemvac Ultra pre-packed with DePuy I Bone Cement: K021499 5 === Pa… | 2004 |
| * | K021499 | Cemvac Ultra Pre-Packed with Depuy 1 Bone CementSummary page 1…SmartSet GMV Endurance Gentamicin Bone Cement: K033382 and K041656 Cemvac Ultra pre-packed with DePuy I Bone Cement: K021499 5 DEVICE DESCRIPTIONS AND INDICATIONS: SmartMix Cemvac SmartMix Cemva… | 2002 |
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 |
|---|---|---|---|
| K053445 | Smartmix Cemvac Pre-Filled with Smartset HV Bone Cement | 2006 | 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 20 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 4 of the 11 ancestors have a recall of any class.
- Of its descendants, K053445 (DePuy Orthopaedics, Inc., 2006) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate P960001.
How does its category compare?
All KIH devicesKIH Dispenser, Cement: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KIH
FDA has decided no KIH device since 2007.
Median 510(k) review, days · KIH
Too few KIH 510(k)s in any year since 2007 to give a median.
Recalls per year · KIH
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KIH
90in 2025
MAUDE reports naming product code KIH, 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 | 0 | — | 0 | 9 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 29 |
| 2011 | 0 | — | 1 | 10 |
| 2012 | 0 | — | 1 | 3 |
| 2013 | 0 | — | 0 | 12 |
| 2014 | 0 | — | 0 | 12 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 14 |
| 2018 | 0 | — | 0 | 15 |
| 2019 | 0 | — | 0 | 30 |
| 2020 | 0 | — | 0 | 23 |
| 2021 | 0 | — | 0 | 30 |
| 2022 | 0 | — | 0 | 26 |
| 2023 | 0 | — | 0 | 30 |
| 2024 | 0 | — | 0 | 19 |
| 2025 | 0 | — | 0 | 90 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
SmartSet MV Endurance 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.
SmartSet GMV Endurance 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/K042591 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042591: Smartmix Pre-Filled Mixing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042591
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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