510(k) · Cleared
ClearedMobileLink Acetabular Cup System - inhouse coatings
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 May 16, 2025 as substantially equivalent to K241636 (Waldemar Link GmbH & Co. KG, 2024) after a 147-day review. Its family tree reaches back 16 generations to 1981.
- Decided
- May 16, 2025
- Review
- 147 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K810258 (1981). 209 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 backK182321 MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG · 2019
- 2 generations backK192559 Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG · 2019
- 1 generation backK241636 MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG · 2024
- This deviceK243927 MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG · 2025
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 backK122305 Corin Trinity-I Acetabular ShellCorin USA · 2012
- 4 generations backK123705 Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA · 2013 · Recalled
- 3 generations backK182321 MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG · 2019
- 2 generations backK192559 Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG · 2019
- 1 generation backK241636 MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG · 2024
- This deviceK243927 MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG · 2025
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 | K122305 | Corin Trinity-I Acetabular Shell | Corin USA | 2012 | — |
| −4 | K123705 | Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular Shells | Corin USA | 2013 | 4 |
| −3 | K182321 | MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | 2019 | — |
| −2 | K192559 | Acetabular Bone Screws (for MobileLink Acetabular Cup System) | Waldemar Link GmbH & Co. KG | 2019 | — |
| −1 | K241636 | MobileLink Acetabular Cup System - Line Extension (Multiple) | Waldemar Link GmbH & Co. KG | 2024 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K241636 | MobileLink Acetabular Cup System - Line Extension (Multiple)Summary page 5…Number MobileLink Acetabular Cup System, MobileLink Acetabular Cup System K241636 PlasmaLink and TiCaP [Primary Predicate] Shells Reference Devices… | 2024 |
| † | K171273 | LINK® BiMobile (TM) Dual Mobility System | 2018 |
| † | K182321 | MobileLink Acetabular Cup System | 2019 |
| † | K213770 | SP-CL Hip Stem and LCU Hip System | 2022 |
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 44 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 51 of the 208 ancestors have a recall of any class.
- 1 other device also cites its predicate K241636.
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. 2025, 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?
General Indications: The MobileLink Acetabular Cup System is indicated for mobility-limiting diseases, fractures or defects of the hip joint or proximal femur which cannot be treated by conservative or osteosynthetic procedures. Indications: - 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…
Read the full statement (133 words)
General Indications:
The MobileLink Acetabular Cup System is indicated for mobility-limiting diseases, fractures or defects of the hip joint or proximal femur which cannot be treated by conservative or osteosynthetic procedures.
Indications:
- 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
Dual Mobility Insert (in addition to the indications and general indications):
- Dislocation risk
The MobileLink Acetabular Shells are intended for cementless fixation.
The TrabecuLink Augments are intended for cementless fixation to the bone and for cemented fixation to the mating shell.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243927 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243927: MobileLink Acetabular Cup System - inhouse coatings.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243927
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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