510(k) · Cleared
Recalled · Class II · 2024BiMobile Dual Mobility System - E-Dur Inserts
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Waldemar Link GmbH & Co. KG · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Aug 6, 2019 as substantially equivalent to K171273 (Waldemar Link GmbH & Co. KG, 2018) and 3 other predicates after a 155-day review. Its family tree reaches back 14 generations to 1981. 3 later devices descend from it. It has been recalled once.
- Decided
- Aug 6, 2019
- Review
- 155 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 14 generations to K810258 (1981). 215 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 10 generations between
- 3 generations backK130343 Corin Trinity Acetabular System with Extra-Long HeadsCorin USA · 2013 · Recalled
- 2 generations backK131647 Trinity Acetabular SystemCorin USA · 2013
- 1 generation backK170359 Trinity™ Dual Mobility SystemCorin U.S.A. Limited · 2017 · Recalled
- This deviceK190535 BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG · 2019
- Descendant · cites it directly · 1 of its ownK200607 LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and…Waldemar Link GmbH & Co. KG · 2021 · Recalled
- Descendant · 2 generations on · 0 of its ownK222066 LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG · 2023
- Descendant · cites it directly · 0 of its ownK211567 BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG · 2022
Show all 14 generations
- Root · 14 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 13 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 12 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 11 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 10 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 9 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 8 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 7 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 6 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- 5 generations backK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
- 4 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- 3 generations backK130343 Corin Trinity Acetabular System with Extra-Long HeadsCorin USA · 2013 · Recalled
- 2 generations backK131647 Trinity Acetabular SystemCorin USA · 2013
- 1 generation backK170359 Trinity™ Dual Mobility SystemCorin U.S.A. Limited · 2017 · Recalled
- This deviceK190535 BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG · 2019
Most influential descendants
Showing 3 of 3 · See all- K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG · 2021 · cites it directly1descendant
- K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG · 2023 · 2 generations on0descendants
- K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −13 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −12 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −11 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −10 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −9 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −8 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −7 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −6 | K100412 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2010 | — |
| −5 | K103120 | Corin Biolox Delta Femoral Heads | Corin USA | 2011 | — |
| −4 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
| −3 | K130343 | Corin Trinity Acetabular System with Extra-Long Heads | Corin USA | 2013 | 2 |
| −2 | K131647 | Trinity Acetabular System | Corin USA | 2013 | — |
| −1 | K170359 | Trinity™ Dual Mobility System | Corin U.S.A. Limited | 2017 | 1 |
| 0 (this device) | K190535 | BiMobile Dual Mobility System - E-Dur Inserts | Waldemar Link GmbH & Co. KG | 2019 | — |
| +1 | K200607 | LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and… | Waldemar Link GmbH & Co. KG | 2021 | 1 |
| +2 | K222066 | LINK MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | 2023 | — |
| +1 | K211567 | BiMobile Instruments (for BiMobile Dual Mobility System) | Waldemar Link GmbH & Co. KG | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 3 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 4 | 0 |
| 1994 | 20 | 0 |
| 1995 | 11 | 0 |
| 1996 | 13 | 0 |
| 1997 | 10 | 0 |
| 1998 | 5 | 0 |
| 1999 | 12 | 0 |
| 2000 | 20 | 0 |
| 2001 | 11 | 0 |
| 2002 | 10 | 0 |
| 2003 | 9 | 0 |
| 2004 | 10 | 0 |
| 2005 | 8 | 0 |
| 2006 | 2 | 0 |
| 2007 | 7 | 0 |
| 2008 | 1 | 0 |
| 2009 | 7 | 0 |
| 2010 | 6 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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? (4)
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 |
|---|---|---|---|
| * | K171273 | LINK® BiMobile (TM) Dual Mobility SystemSummary page 4…§888.3353, product code MEH Classification and Panel: Class II, Orthopedic / 87 Predicate Devices: LINK BiMobile Dual Mobility System, K171273, cleared January 19, 2018 Trinity Dual Mobility System with ECiMa Liners… | 2018 |
| * | K170359 | Trinity™ Dual Mobility SystemSummary page 4…3, cleared January 19, 2018 Trinity Dual Mobility System with ECiMa Liners by Corin, K170359, cleared October 31, 2017 EXp Acetabular Shell Liner by Stelkast, Inc., K094035,… | 2017 |
| * | K094035 | Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MMSummary page 4…stem with ECiMa Liners by Corin, K170359, cleared October 31, 2017 EXp Acetabular Shell Liner by Stelkast, Inc., K094035, cleared March 24, 2011 MobileLink Acetabular Cup System, K182321, clear… | 2011 |
| * | K182321 | MobileLink Acetabular Cup System Cleared while this submission was under review Summary page 4…EXp Acetabular Shell Liner by Stelkast, Inc., K094035, cleared March 24, 2011 MobileLink Acetabular Cup System, K182321, cleared May 24, 2019 Device Description: The BiMobile cup system is a dual mobility acetabu… | 2019 |
What descends from it? (3)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 22, 2024 | Class II | Z-1219-2024 | Under Investigation by firm | Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 38 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 58 of the 214 ancestors have a recall of any class.
- Of its descendants, K200607 (Waldemar Link GmbH & Co. KG, 2021) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K171273.
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. 2019, 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?
The BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects of the
hip joint or proximal femur, which cannot be treated by conservative or osteosynthetic procedures.
The BiMobile Dual Mobility System is indicated for the following conditions:
• Primary and secondary osteoarthritis
• Rheumatoid arthritis
• Correction of functional deformities
• Avascular necrosis
• Femoral neck fractures
• Revision after implant loosening dependent on bone mass and quality
• Dislocation risks
The device is intended for cemented and cementless use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190535 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190535: BiMobile Dual Mobility System - E-Dur Inserts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190535
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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