510(k) · Cleared
Recalled · Class II · 2018LINK® BiMobile (TM) 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 · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Jan 19, 2018 as substantially equivalent to K072020 (Howmedica Osteonics Corp., 2007) and 2 other predicates after a 263-day review. Its family tree reaches back 7 generations to 1996. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 19, 2018
- Review
- 263 days
- Class
- Class II
- Product code
- MEH
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 7 generations to K955033 (1996). 53 ancestors in all, the oldest K840643 (1984). 4 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
- 6 generations backK983509 Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc. · 1999
- 5 generations backK993259 Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc. · 2000 · Recalled
- 4 generations backK022902 Smith & Nephew Hip SystemSmith & Nephew, Inc. · 2002
- 3 generations backK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
- 2 generations backK043079 Bicontact Hip System with U-CapAesculap · 2004
- 1 generation backK093472 Trinity Acetabular SystemCorin USA · 2010 · Recalled
- This deviceK171273 LINK® BiMobile (TM) Dual Mobility SystemWaldemar Link GmbH & Co. KG · 2018
- Descendant · cites it directly · 3 of its ownK190535 BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG · 2019 · Recalled
- Descendant · 2 generations on · 1 of its ownK200607 LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and…Waldemar Link GmbH & Co. KG · 2021 · Recalled
- Descendant · 3 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
Most influential descendants
Showing 4 of 4 · See all- K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG · 2019 · cites it directly3descendants
- K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG · 2021 · 2 generations on1descendant
- K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG · 2023 · 3 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 |
|---|---|---|---|---|---|
| −7 | K955033 | Rim Flare Acetabular Component | Intermedics Orthopedics | 1996 | — |
| −6 | K983509 | Inter-OP Acetabular System - Durasul Acetabular Insert | Sulzer Orthopedics, Inc. | 1999 | — |
| −5 | K993259 | Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads | Sulzer Orthopedics, Inc. | 2000 | 3 |
| −4 | K022902 | Smith & Nephew Hip System | Smith & Nephew, Inc. | 2002 | — |
| −3 | K040191 | Bicontact Hip Stem and Femoral Head | Aesculap | 2004 | — |
| −2 | K043079 | Bicontact Hip System with U-Cap | Aesculap | 2004 | — |
| −1 | K093472 | Trinity Acetabular System | Corin USA | 2010 | 1 |
| 0 (this device) | K171273 | LINK® BiMobile (TM) Dual Mobility System | Waldemar Link GmbH & Co. KG | 2018 | — |
| +1 | K190535 | BiMobile Dual Mobility System - E-Dur Inserts | Waldemar Link GmbH & Co. KG | 2019 | 1 |
| +2 | K200607 | LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and… | Waldemar Link GmbH & Co. KG | 2021 | 1 |
| +3 | 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 |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2007 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 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 MEH? 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 MEH device
- #1 K210581 Actis DuoFix Hip Prosthesis- Collarlessscore 23.9 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K072020 | Restoration Adm SystemSummary page 4…§888.3353, product code MEH Classification and Panel: Class II, Orthopedic / 87 Predicate Devices: RestorationTM ADM System by Howmedica, K072020, cleared October 18, 2007 Trinity Acetabular System by Corin, K093472, c… | 2007 |
| * | K093472 | Trinity Acetabular SystemSummary page 4…RestorationTM ADM System by Howmedica, K072020, cleared October 18, 2007 Trinity Acetabular System by Corin, K093472, cleared November 23, 2010 NOVAE® Dual Mobility Acetabular Cup by SERF,… | 2010 |
| * | K111572 | Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH (Metal-Back), Novae E TH…Summary page 4…nity Acetabular System by Corin, K093472, cleared November 23, 2010 NOVAE® Dual Mobility Acetabular Cup by SERF, K111572, cleared August 29, 2011 Device Description: The BiMobileTM cup system is a dual mobility ac… | 2011 |
What descends from it? (4)
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 |
|---|---|---|---|---|
| Dec 4, 2018 | Class II | Z-0728-2019 | Employee error | The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records. |
| Dec 4, 2018 | Class II | Z-0729-2019 | Employee error | The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
- 15 of the 52 ancestors have a recall of any class.
- Of its descendants, K190535 (Waldemar Link GmbH & Co. KG, 2019) has gone furthest, with 3 descendants of its own.
- 9 other devices also cite its predicate K072020.
How does its category compare?
All MEH devicesMEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · MEH
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEH
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MEH
470in 2025
MAUDE reports naming product code MEH, 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 | 2 | — | 3 | 25 |
| 2008 | 6 | 79 | 80 | 261 |
| 2009 | 6 | 65 | 51 | 539 |
| 2010 | 5 | 226 | 16 | 462 |
| 2011 | 5 | 95 | 4 | 419 |
| 2012 | 6 | 131 | 3 | 1,606 |
| 2013 | 1 | — | 0 | 1,295 |
| 2014 | 0 | — | 1 | 1,196 |
| 2015 | 2 | — | 1 | 490 |
| 2016 | 6 | 163 | 4 | 347 |
| 2017 | 3 | 209 | 1 | 383 |
| 2018 | 2 | — | 3 | 337 |
| 2019 | 1 | — | 0 | 335 |
| 2020 | 3 | 131 | 1 | 338 |
| 2021 | 3 | 83 | 0 | 372 |
| 2022 | 3 | 150 | 0 | 316 |
| 2023 | 2 | — | 0 | 334 |
| 2024 | 6 | 91 | 0 | 354 |
| 2025 | 5 | 87 | 1 | 470 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The LINK® BiMobile™ Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures.
The LINK® BiMobile™ Dual Mobility System is indicated for the following conditions:
• Primary and secondary coxarthrosis
• Osteoarthritis
• Necrosis of the femoral head
• Femoral neck fractures
• Revision after implant loosening
• Acetabular dysplasia
The device is intended for cemented and cementless use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171273 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171273: LINK® BiMobile (TM) 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/K171273
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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