510(k) · Cleared
ClearedMobileLink Acetabular Cup System - Line Extension (Multiple)
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 Nov 8, 2024 as substantially equivalent to K182321 (Waldemar Link GmbH & Co. KG, 2019) and 7 other predicates after a 155-day review. Its family tree reaches back 15 generations to 1981. 2 later devices descend from it.
- Decided
- Nov 8, 2024
- Review
- 155 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 15 generations to K810258 (1981). 208 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 15 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 11 generations between
- 3 generations backK123705 Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA · 2013 · Recalled
- 2 generations backK182321 MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG · 2019
- 1 generation backK192559 Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG · 2019
- This deviceK241636 MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG · 2024
- Descendant · cites it directly · 0 of its ownK261009 MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG · 2026
- Descendant · cites it directly · 0 of its ownK243927 MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG · 2025
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 backK122305 Corin Trinity-I Acetabular ShellCorin USA · 2012
- 3 generations backK123705 Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA · 2013 · Recalled
- 2 generations backK182321 MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG · 2019
- 1 generation backK192559 Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG · 2019
- This deviceK241636 MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG · 2024
Most influential descendants
Showing 2 of 2 · See allView 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 | K122305 | Corin Trinity-I Acetabular Shell | Corin USA | 2012 | — |
| −3 | K123705 | Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular Shells | Corin USA | 2013 | 4 |
| −2 | K182321 | MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | 2019 | — |
| −1 | K192559 | Acetabular Bone Screws (for MobileLink Acetabular Cup System) | Waldemar Link GmbH & Co. KG | 2019 | — |
| 0 (this device) | K241636 | MobileLink Acetabular Cup System - Line Extension (Multiple) | Waldemar Link GmbH & Co. KG | 2024 | — |
| +1 | K261009 | MobileLink Acetabular Cup System – 40mm ID Inserts (various) | Waldemar Link GmbH & Co. KG | 2026 | — |
| +1 | K243927 | MobileLink Acetabular Cup System - inhouse coatings | Waldemar Link GmbH & Co. KG | 2025 | — |
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 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 4 | 0 |
| 1993 | 5 | 0 |
| 1994 | 23 | 0 |
| 1995 | 11 | 0 |
| 1996 | 15 | 0 |
| 1997 | 11 | 0 |
| 1998 | 5 | 0 |
| 1999 | 10 | 0 |
| 2000 | 20 | 0 |
| 2001 | 10 | 0 |
| 2002 | 9 | 0 |
| 2003 | 7 | 0 |
| 2004 | 10 | 0 |
| 2005 | 9 | 0 |
| 2006 | 3 | 0 |
| 2007 | 6 | 0 |
| 2008 | 1 | 0 |
| 2009 | 7 | 0 |
| 2010 | 5 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 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 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? (8)
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 5…Number MobileLink X- 1. MobileLink Acetabular Cup System, Polyethylene liners in K182321 LINKed Inserts neutral, offset, 10° and 20° inclinations [Primary Predicate] 2. DePuy Pinnacle AltrX… | 2019 |
| * | K062148 | Depuy Pinnacle Altrx Acetabular Cup LinerSummary page 5…Ked Inserts neutral, offset, 10° and 20° inclinations [Primary Predicate] 2. DePuy Pinnacle AltrX Acetabular Cup Liner K062148 DePuy Orthopedics, Inc. MobileLink 1. Trabecular Metal Acetabular Augments… | 2006 |
| * | K061067 | Trabecular Metal Acetabular AugmentsSummary page 5…ner K062148 DePuy Orthopedics, Inc. MobileLink 1. Trabecular Metal Acetabular Augments K061067, TrabecuLink Zimmer, Inc. K042871, Augments 2.… | 2006 |
| * | K042871 | Trabecular Metal Acetabular Augments, Models 4894-XXX-YY, 02-212-105XX3, 02-212-205XX3…Summary page 5…1. Trabecular Metal Acetabular Augments K061067, TrabecuLink Zimmer, Inc. K042871, Augments 2. Restoration Acetabular Wedge Augments Howmedica Osteonics Corp. (Stryker)… | 2004 |
| * | K102019 | Restoration Acetabular Wedge AugmentsSummary page 5…tabular Wedge Augments Howmedica Osteonics Corp. (Stryker) K102019 Bone Screws 1. MobileLink Acetabular Cup System Ø 6.5mm System Bone K192559 screws… | 2011 |
| * | K192559 | Acetabular Bone Screws (for MobileLink Acetabular Cup System)Summary page 5…K102019 Bone Screws 1. MobileLink Acetabular Cup System Ø 6.5mm System Bone K192559 screws K021891,… | 2019 |
| * | K021891 | Zimmer Trabecular Metal Modular Acetabular SystemSummary page 5…Cup System Ø 6.5mm System Bone K192559 screws K021891, 2. Trilogy or Trabecular Metal Acetabular Cup Ø 4.5mm Screws… | 2002 |
| * | K934765 | Trilogy Acetabular SystemSummary page 5…2. Trilogy or Trabecular Metal Acetabular Cup Ø 4.5mm Screws K934765 (Zimmer) Reason for New Device System Components Submission Device The MobileLink Ace… | 1994 |
What descends from it? (2)
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)
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 43 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 51 of the 207 ancestors have a recall of any class.
- Of its descendants, K261009 (Waldemar Link GmbH & Co. KG, 2026) has gone furthest, with 0 descendants of its own.
- 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. 2024, 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?
The MobileLink Acetabular Cup 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. 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…
Read the full statement (130 words)
The MobileLink Acetabular Cup 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.
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
Additional indications specific to the TrabecuLink Augments:
Primary or revision surgery for hip replacement as a prosthetic alternative to structural allograft in
cases of segmental acetabular deficiencies.
The MobileLink Acetabular Shells are intended for cementless fixation. The TrabeculLink Augments
are intended for cementless fixation to the bone and for cemented fixation to the mating shell.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K241636 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241636: MobileLink Acetabular Cup System - Line Extension (Multiple).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241636
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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