510(k) · Cleared
ClearedLINK MobileLink Acetabular Cup System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Waldemar Link GmbH & Co. KG · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Apr 14, 2023 as substantially equivalent to K182321 (Waldemar Link GmbH & Co. KG, 2019) and 3 other predicates after a 275-day review. Its family tree reaches back 16 generations to 1981.
- Decided
- Apr 14, 2023
- Review
- 275 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 16 generations to K810258 (1981). 245 ancestors in all. No later device cites it as a predicate yet.
- Root · 16 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 12 generations between
- 3 generations backK170359 Trinity™ Dual Mobility SystemCorin U.S.A. Limited · 2017 · Recalled
- 2 generations backK190535 BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG · 2019 · Recalled
- 1 generation backK200607 LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and…Waldemar Link GmbH & Co. KG · 2021 · Recalled
- This deviceK222066 LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG · 2023
Show all 16 generations
- Root · 16 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 15 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 14 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 13 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 12 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 11 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 10 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 9 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 8 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- 7 generations backK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
- 6 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- 5 generations backK130343 Corin Trinity Acetabular System with Extra-Long HeadsCorin USA · 2013 · Recalled
- 4 generations backK131647 Trinity Acetabular SystemCorin USA · 2013
- 3 generations backK170359 Trinity™ Dual Mobility SystemCorin U.S.A. Limited · 2017 · Recalled
- 2 generations backK190535 BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG · 2019 · Recalled
- 1 generation backK200607 LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and…Waldemar Link GmbH & Co. KG · 2021 · Recalled
- This deviceK222066 LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −15 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −14 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −13 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −12 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −11 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −10 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −9 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −8 | K100412 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2010 | — |
| −7 | K103120 | Corin Biolox Delta Femoral Heads | Corin USA | 2011 | — |
| −6 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
| −5 | K130343 | Corin Trinity Acetabular System with Extra-Long Heads | Corin USA | 2013 | 2 |
| −4 | K131647 | Trinity Acetabular System | Corin USA | 2013 | — |
| −3 | K170359 | Trinity™ Dual Mobility System | Corin U.S.A. Limited | 2017 | 1 |
| −2 | K190535 | BiMobile Dual Mobility System - E-Dur Inserts | Waldemar Link GmbH & Co. KG | 2019 | 1 |
| −1 | K200607 | LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and… | Waldemar Link GmbH & Co. KG | 2021 | 1 |
| 0 (this device) | K222066 | LINK MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 4 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 5 | 0 |
| 1993 | 5 | 0 |
| 1994 | 24 | 0 |
| 1995 | 14 | 0 |
| 1996 | 17 | 0 |
| 1997 | 11 | 0 |
| 1998 | 6 | 0 |
| 1999 | 12 | 0 |
| 2000 | 22 | 0 |
| 2001 | 11 | 0 |
| 2002 | 10 | 0 |
| 2003 | 9 | 0 |
| 2004 | 11 | 0 |
| 2005 | 9 | 0 |
| 2006 | 2 | 0 |
| 2007 | 8 | 0 |
| 2008 | 2 | 0 |
| 2009 | 9 | 0 |
| 2010 | 6 | 0 |
| 2011 | 6 | 0 |
| 2012 | 5 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 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 LPH? 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 LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 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 |
|---|---|---|---|
| * | K182321 | MobileLink Acetabular Cup SystemSummary page 4…ents Number TrabecuLink 1. MobileLink Acetabular Cup System K182321, Shells Pro Codes: LPH, LZO, MEH, OQG K192559,… | 2019 |
| * | K192559 | Acetabular Bone Screws (for MobileLink Acetabular Cup System)Summary page 4…ink 1. MobileLink Acetabular Cup System K182321, Shells Pro Codes: LPH, LZO, MEH, OQG K192559, Waldemar Link GmbH & Co KG K200607… | 2019 |
| * | K200607 | LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersSummary page 4…Pro Codes: LPH, LZO, MEH, OQG K192559, Waldemar Link GmbH & Co KG K200607 [Primary Predicate] 2. G7 OsseoTi Acetabular Shell… | 2021 |
| * | K140669 | G7 Osseoti Acetublar ShellsSummary page 4…Pro Codes: LPH, JDI, KWZ, LZO, OQG, OQH, OQI, PBI Biomet, Inc. (Zimmer Biomet) K140669 Reason for New Device System Components – TrabecuLink Shells Submission Device This 510k adds Mobi… | 2014 |
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 42 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 67 of the 244 ancestors have a recall of any class.
- 5 other devices also cite its predicate K182321.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, 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 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
General indications:
Mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures.
Indications:
1) Primary and secondary osteoarthritis
2) Rheumatoid arthritis
3) Correction of functional deformities
4) Avascular necrosis
5) Femoral neck fractures
6) Revision after implant loosening dependent on bone mass and quality
The MobileLink Dual Mobility Insert is additionally indicated for: 7) Dislocation risks
The MobileLink Acetabular Shells are intended for cementless fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222066 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222066: LINK MobileLink Acetabular Cup System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222066
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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