510(k) · Cleared
ClearedBI-MENTUM™ ALTRX® Dual Mobility Liner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Ireland UC · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Apr 28, 2021 as substantially equivalent to K181744 (Serf, 2018) after a 147-day review. Its family tree reaches back 4 generations to 1999. 6 later devices descend from it.
- Decided
- Apr 28, 2021
- Review
- 147 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K991990 (1999). 5 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- 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 deviceK203532 BI-MENTUM™ ALTRX® Dual Mobility LinerDepuy Ireland UC · 2021
- Descendant · cites it directly · 5 of its ownK231873 DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT…Depuy Ireland UC · 2024
- Descendant · 2 generations on · 1 of its ownK251292 RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC · 2025
- Descendant · 2 generations on · 1 of its ownK243977 EMPHASYS Acetabular SystemDepuy Ireland UC · 2025
- Descendant · 3 generations on · 0 of its ownK260173 M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026
- Descendant · 3 generations on · 0 of its ownK252067 Velora Acetabular SystemRestor3D, Inc. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC · 2024 · cites it directly5descendants
- K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC · 2025 · 2 generations on1descendant
- K243977EMPHASYS Acetabular SystemDepuy Ireland UC · 2025 · 2 generations on1descendant
- K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026 · 3 generations on0descendants
- K252067Velora Acetabular SystemRestor3D, Inc. · 2025 · 3 generations on0descendants
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) | K203532 | BI-MENTUM™ ALTRX® Dual Mobility Liner | Depuy Ireland UC | 2021 | — |
| +1 | K231873 | DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip… | Depuy Ireland UC | 2024 | — |
| +2 | K251292 | RECLAIM Monobloc Revision Femoral Stem | Depuy Ireland UC | 2025 | — |
| +2 | K243977 | EMPHASYS Acetabular System | Depuy Ireland UC | 2025 | — |
| +3 | K260173 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | 2026 | — |
| +3 | K252067 | Velora Acetabular System | Restor3D, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 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 LZO? 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 LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231873 | DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip… | 2024 | 5 |
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 22 years and passes through 4 companies; a new generation was cleared every 7.3 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K231873 (Depuy Ireland UC, 2024) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K181744.
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, 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 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
What is it indicated for?
BI-MENTUMTm ALTRX@ Dual Mobility System is indicated for total hip replacement in the following conditions:
- Osteoarthritis
- Femoral neck fracture
- Dislocation risk
- Osteonecrosis of the femoral head
- Revision procedures where other treatments or devices have failed and if bone reconstruction so permits
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203532 · printed Nov 4, 2026
Cite this page
510(k) Report. “K203532: BI-MENTUM™ ALTRX® Dual Mobility Liner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K203532
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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