510(k) · Cleared
ClearedCemvac Ultra Pre-Packed with Depuy 1 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 Jul 24, 2002 as substantially equivalent to P960001 (Depuy, Inc., 1997) and 2 other predicates after a 76-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it.
- Decided
- Jul 24, 2002
- Review
- 76 days
- Class
- Class II
- Product code
- LOD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to P960001 (1997). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backP960001 Depuy 1 Bone CementDepuy, Inc. · 1997
- This deviceK021499 Cemvac Ultra Pre-Packed with Depuy 1 Bone CementDePuy Orthopaedics, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK042591 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P960001 | Depuy 1 Bone Cement | Depuy, Inc. | 1997 | — |
| 0 (this device) | K021499 | Cemvac Ultra Pre-Packed with Depuy 1 Bone Cement | DePuy Orthopaedics, Inc. | 2002 | — |
| +1 | 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 |
|---|---|---|
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 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 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.
What descends from it? (2)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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?
CEMVAC Ultra pre-packed with DePuy 1 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/K021499 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021499: Cemvac Ultra Pre-Packed with Depuy 1 Bone Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021499
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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