510(k) · Cleared
ClearedProstalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Ireland UC · KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Cleared on May 15, 2026 as substantially equivalent to K081155 (DePuy Orthopaedics, Inc., 2008) after an 87-day review. Its family tree reaches back 3 generations to 1984.
- Decided
- May 15, 2026
- Review
- 87 days
- Class
- Class II
- Product code
- KWL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to P810020 (1984). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backP810020 Palacos R Bone CementSmith & Nephew Richards, Inc. · 1984 · Recalled
- 2 generations backK023012 Smartset HV Bone CementDePuy Orthopaedics, Inc. · 2003
- 1 generation backK081155 Smartset MV Bone CementDePuy Orthopaedics, Inc. · 2008
- This deviceK260536 Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CementDepuy Ireland UC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P810020 | Palacos R Bone Cement | Smith & Nephew Richards, Inc. | 1984 | 1 |
| −2 | K023012 | Smartset HV Bone Cement | DePuy Orthopaedics, Inc. | 2003 | — |
| −1 | K081155 | Smartset MV Bone Cement | DePuy Orthopaedics, Inc. | 2008 | — |
| 0 (this device) | 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 |
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 KWL? 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 KWL device
- #1 K253675 OsteoRemedies Hip Spacer Systemscore 16.0 · 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 |
|---|---|---|---|
| * | K081155 | Smartset MV Bone CementSummary page 5…cation II III. Predicate Predicate and Reference DePuy Prostalac Hip System (H000004 – March 19, 2001) Devices For use with SmartSet MV Bone Cement (K081155) Reference Biomet, Inc. StageOne Select Hip Cement Spacer Molds (K222760) For… | 2008 |
| * | — | DePuy Prostalac Hip System Named without a submission number | |
| † | K222760 | StageOne™ Select Hip Cement Spacer Molds | 2022 |
| † | K171540 | Refobacin Bone Cement R | 2017 |
| † | K172906 | REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement | 2018 |
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 42 years and passes through 3 companies; a new generation was cleared every 18.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All KWL devicesKWL Prosthesis, Hip, Hemi-, Femoral, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · KWL
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWL
32in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWL
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWL
29in 2025
MAUDE reports naming product code KWL, 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 | — | 36 | 11 |
| 2008 | 1 | — | 0 | 13 |
| 2009 | 0 | — | 2 | 21 |
| 2010 | 0 | — | 0 | 55 |
| 2011 | 2 | — | 0 | 51 |
| 2012 | 1 | — | 0 | 62 |
| 2013 | 0 | — | 0 | 89 |
| 2014 | 0 | — | 0 | 107 |
| 2015 | 1 | — | 1 | 223 |
| 2016 | 0 | — | 0 | 210 |
| 2017 | 0 | — | 2 | 347 |
| 2018 | 2 | — | 0 | 294 |
| 2019 | 1 | — | 0 | 415 |
| 2020 | 1 | — | 0 | 270 |
| 2021 | 0 | — | 0 | 107 |
| 2022 | 1 | — | 0 | 99 |
| 2023 | 0 | — | 0 | 48 |
| 2024 | 1 | — | 0 | 143 |
| 2025 | 3 | 32 | 0 | 29 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The PROSTALAC Hip System is indicated for use as a short-term total hip replacement (THR) in patients who need a two-stage procedure to treat a confirmed infection of their THR and where vancomycin combined with either tobramycin OR gentamicin are the most appropriate antibiotics for treatment of the infection based on the susceptibility pattern of the infecting microorganism(s).
SmartSet V+G Dual Antibiotic Bone Cement is intended for use with the DePuy Prostalac Hip System. The SmartSet V+G Dual Antibiotic Bone Cement is indicated for the formation and fixation of the DePuy Prostalac Hip System to the host bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260536 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260536: Prostalac Hip System, SmartSet V+G Dual Antibiotic 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/K260536
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026