510(k) · Cleared
ClearedBiMobile Instruments (for BiMobile Dual Mobility System)
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 Jun 3, 2022 as substantially equivalent to K171273 (Waldemar Link GmbH & Co. KG, 2018) and 1 other predicate after a 378-day review. Its family tree reaches back 15 generations to 1981.
- Decided
- Jun 3, 2022
- Review
- 378 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K810258 (1981). 216 ancestors in all. No later device cites it as a predicate yet.
- Root · 15 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 11 generations between
- 3 generations backK131647 Trinity Acetabular SystemCorin USA · 2013
- 2 generations backK170359 Trinity™ Dual Mobility SystemCorin U.S.A. Limited · 2017 · Recalled
- 1 generation backK190535 BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG · 2019 · Recalled
- This deviceK211567 BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG · 2022
Show all 15 generations
- Root · 15 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 14 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 13 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 12 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 11 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 10 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 9 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 8 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 7 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- 6 generations backK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
- 5 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- 4 generations backK130343 Corin Trinity Acetabular System with Extra-Long HeadsCorin USA · 2013 · Recalled
- 3 generations backK131647 Trinity Acetabular SystemCorin USA · 2013
- 2 generations backK170359 Trinity™ Dual Mobility SystemCorin U.S.A. Limited · 2017 · Recalled
- 1 generation backK190535 BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG · 2019 · Recalled
- This deviceK211567 BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −14 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −13 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −12 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −11 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −10 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −9 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −8 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −7 | K100412 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2010 | — |
| −6 | K103120 | Corin Biolox Delta Femoral Heads | Corin USA | 2011 | — |
| −5 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
| −4 | K130343 | Corin Trinity Acetabular System with Extra-Long Heads | Corin USA | 2013 | 2 |
| −3 | K131647 | Trinity Acetabular System | Corin USA | 2013 | — |
| −2 | K170359 | Trinity™ Dual Mobility System | Corin U.S.A. Limited | 2017 | 1 |
| −1 | K190535 | BiMobile Dual Mobility System - E-Dur Inserts | Waldemar Link GmbH & Co. KG | 2019 | 1 |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K171273 | LINK® BiMobile (TM) Dual Mobility SystemSummary page 4…ed, metal/polymer, non- porous, calcium-phosphate; 21 CFR §888.3353, product code MEH Predicate Devices: LINK BiMobile Dual Mobility System, K171273, cleared January 19, 2018 LINK BiMobile Dual Mobility System – E-Dur Inserts, K1905… | 2018 |
| * | K190535 | BiMobile Dual Mobility System - E-Dur InsertsSummary page 4…LINK BiMobile Dual Mobility System, K171273, cleared January 19, 2018 LINK BiMobile Dual Mobility System – E-Dur Inserts, K190535, cleared August 6, 2019 Device Description: The BiMobile instruments are considered a line extension t… | 2019 |
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 41 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 59 of the 215 ancestors have a recall of any class.
- 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. 2022, 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 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 coxarthrosis
* 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/K211567 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211567: BiMobile Instruments (for BiMobile 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/K211567
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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