510(k) · Cleared
ClearedEMPHASYS™ Dual Mobility System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Ireland UC · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Feb 15, 2024 as substantially equivalent to K200854 (Depuy Ireland UC, 2020) and 1 other predicate after a 265-day review. Its family tree reaches back 4 generations to 1999.
- Decided
- Feb 15, 2024
- Review
- 265 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K991990 (1999). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK991990 Tri-Polar SystemBiomet, Inc. · 1999
- 3 generations backK070278 Polarcup Dual Mobility SystemPlus Orthopedics AG · 2007
- 2 generations backK111572 Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH…Serf · 2011 · Recalled
- 1 generation backK181744 BI-MENTUM dual mobility systemSerf · 2018
- This deviceK231522 EMPHASYS™ Dual Mobility SystemDepuy Ireland UC · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K991990 | Tri-Polar System | Biomet, Inc. | 1999 | — |
| −3 | K070278 | Polarcup Dual Mobility System | Plus Orthopedics AG | 2007 | — |
| −2 | K111572 | Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH (Metal-Back)… | Serf | 2011 | 5 |
| −1 | K181744 | BI-MENTUM dual mobility system | Serf | 2018 | — |
| 0 (this device) | K231522 | EMPHASYS™ Dual Mobility System | Depuy Ireland UC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2020 | 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 LPH? 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 LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 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 |
|---|---|---|---|
| * | K200854 | DePuy PINNACLE Dual Mobility LinerSummary page 6…ual Mobility Dual Mobility Conditional, DePuy SUMMIT Liners Liners Cemented Hip Prosthesis – (K200854) MR Conditional, DePuy SUMMIT FX Cemented Hip… | 2020 |
| * | K181744 | BI-MENTUM dual mobility systemSummary page 6…sis – MR Bearing System Conditional, DePuy SUMMIT Heads (K181744) Cemented Hip Prosthesis –… | 2018 |
| † | K103233 | Modular Dual Mobility Liner, X3 Acetabular Insert | 2011 |
| † | K150522 | G7 Dual Mobility System | 2015 |
| † | K231873 | DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip… | 2024 |
| † | K221636 | EMPHASYS Acetabular System | 2022 |
| † | K232667 | OR3O Dual Mobility Liners | 2023 |
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 25 years and passes through 4 companies; a new generation was cleared every 7.3 years on median.
- 4 of the 9 ancestors have a recall of any class.
- 1 other device also cites its predicate K200854.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, 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 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
Total hip replacement is indicated in the following conditions:
1. A severely painful and/or disabled joint (typically due to non-inflammatory degenerative joint disease).
2. Failed previous hip surgery.
3. Dislocation risks.
EMPHASYS Dual Mobility Liners and Mobile Bearing Heads are intended for cementless applications.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K231522 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231522: EMPHASYS™ Dual Mobility System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231522
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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