510(k) · Cleared
ClearedBI-MENTUM dual mobility system
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Serf · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Dec 11, 2018 as substantially equivalent to K111572 (Serf, 2011) after a 162-day review. Its family tree reaches back 3 generations to 1999. 10 later devices descend from it.
- Decided
- Dec 11, 2018
- Review
- 162 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K991990 (1999). 4 ancestors in all. 10 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK991990 Tri-Polar SystemBiomet, Inc. · 1999
- 2 generations backK070278 Polarcup Dual Mobility SystemPlus Orthopedics AG · 2007
- 1 generation backK111572 Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH…Serf · 2011 · Recalled
- This deviceK181744 BI-MENTUM dual mobility systemSerf · 2018
- Descendant · cites it directly · 6 of its ownK203532 BI-MENTUM™ ALTRX® Dual Mobility LinerDepuy Ireland UC · 2021
- Descendant · 2 generations on · 5 of its ownK231873 DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT…Depuy Ireland UC · 2024
- Descendant · 3 generations on · 1 of its ownK251292 RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC · 2025
- Descendant · 3 generations on · 1 of its ownK243977 EMPHASYS Acetabular SystemDepuy Ireland UC · 2025
- Descendant · cites it directly · 1 of its ownK223745 Novae® Dual Mobility System, Hype® Hip SystemSerf · 2023
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K203532BI-MENTUM™ ALTRX® Dual Mobility LinerDepuy Ireland UC · 2021 · cites it directly6descendants
- K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC · 2024 · 2 generations on5descendants
- K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC · 2025 · 3 generations on1descendant
- K243977EMPHASYS Acetabular SystemDepuy Ireland UC · 2025 · 3 generations on1descendant
- K223745Novae® Dual Mobility System, Hype® Hip SystemSerf · 2023 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K991990 | Tri-Polar System | Biomet, Inc. | 1999 | — |
| −2 | K070278 | Polarcup Dual Mobility System | Plus Orthopedics AG | 2007 | — |
| −1 | K111572 | Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH (Metal-Back)… | Serf | 2011 | 5 |
| 0 (this device) | K181744 | BI-MENTUM dual mobility system | Serf | 2018 | — |
| +1 | K203532 | BI-MENTUM™ ALTRX® Dual Mobility Liner | Depuy Ireland UC | 2021 | — |
| +2 | K231873 | DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip… | Depuy Ireland UC | 2024 | — |
| +3 | K251292 | RECLAIM Monobloc Revision Femoral Stem | Depuy Ireland UC | 2025 | — |
| +3 | K243977 | EMPHASYS Acetabular System | Depuy Ireland UC | 2025 | — |
| +1 | K223745 | Novae® Dual Mobility System, Hype® Hip System | Serf | 2023 | — |
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 |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K111572 | Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH (Metal-Back), Novae E TH…Summary page 5…1. Substantialequivalenceclaimedtopredicatedevices BIͲMENTUMTMdualmobilitysystemisthesameproductasNOVAE®DualMobilityAcetabular Cupclearedin2011(K111572,SERF). Thereisnochangeinthedesignoftheacetabularcup,nochangeinthefundamentalscientific technologyofthedevic… | 2011 |
What descends from it? (10)
3 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?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 7.3 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K203532 (Depuy Ireland UC, 2021) has gone furthest, with 6 descendants of its own.
- 9 other devices also cite its predicate K111572.
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. 2018, 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-MENTUM™ Dual Mobility System is indicated for total hip replacement, which includes:
- 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
BI-MENTUM™ PressFit Cup, BI-MENTUM™ Plus Cup and BI-MENTUM™ Revision Cup are intended for press-fit use and BI-MENTUM™ Cemented Cup is indicated for cemented use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181744 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181744: BI-MENTUM 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/K181744
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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