510(k) · Cleared
ClearedMobileLink 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 · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on May 24, 2019 as substantially equivalent to K121874 (Biomet Manufacturing Corp, 2012) and 5 other predicates after a 270-day review. Its family tree reaches back 13 generations to 1981. 8 later devices descend from it.
- Decided
- May 24, 2019
- Review
- 270 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 13 generations to K810258 (1981). 171 ancestors in all. 8 later devices descend from it, 6 citing it directly.
- Root · 13 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 9 generations between
- 3 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- 2 generations backK122305 Corin Trinity-I Acetabular ShellCorin USA · 2012
- 1 generation backK123705 Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA · 2013 · Recalled
- This deviceK182321 MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG · 2019
- Descendant · cites it directly · 4 of its ownK192559 Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG · 2019
- Descendant · cites it directly · 3 of its ownK190535 BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG · 2019 · Recalled
- Descendant · cites it directly · 2 of its ownK241636 MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG · 2024
- Descendant · cites it directly · 1 of its ownK200607 LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and…Waldemar Link GmbH & Co. KG · 2021 · Recalled
- Descendant · cites it directly · 0 of its ownK261009 MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG · 2026
Show all 13 generations
- Root · 13 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 12 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 11 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 10 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 9 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 8 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 7 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 6 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 5 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- 4 generations backK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
- 3 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- 2 generations backK122305 Corin Trinity-I Acetabular ShellCorin USA · 2012
- 1 generation backK123705 Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA · 2013 · Recalled
- This deviceK182321 MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG · 2019
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG · 2019 · cites it directly4descendants
- K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG · 2019 · cites it directly3descendants
- K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG · 2024 · cites it directly2descendants
- K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG · 2021 · cites it directly1descendant
- K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −12 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −11 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −10 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −9 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −8 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −7 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −6 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −5 | K100412 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2010 | — |
| −4 | K103120 | Corin Biolox Delta Femoral Heads | Corin USA | 2011 | — |
| −3 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
| −2 | K122305 | Corin Trinity-I Acetabular Shell | Corin USA | 2012 | — |
| −1 | K123705 | Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular Shells | Corin USA | 2013 | 4 |
| 0 (this device) | 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 | — |
| +1 | K190535 | BiMobile Dual Mobility System - E-Dur Inserts | Waldemar Link GmbH & Co. KG | 2019 | 1 |
| +1 | K241636 | MobileLink Acetabular Cup System - Line Extension (Multiple) | Waldemar Link GmbH & Co. KG | 2024 | — |
| +1 | K200607 | LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and… | Waldemar Link GmbH & Co. KG | 2021 | 1 |
| +1 | K261009 | MobileLink Acetabular Cup System – 40mm ID Inserts (various) | Waldemar Link GmbH & Co. KG | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 2 | 0 |
| 1993 | 4 | 0 |
| 1994 | 19 | 0 |
| 1995 | 8 | 0 |
| 1996 | 11 | 0 |
| 1997 | 9 | 0 |
| 1998 | 4 | 0 |
| 1999 | 10 | 0 |
| 2000 | 17 | 0 |
| 2001 | 9 | 0 |
| 2002 | 9 | 0 |
| 2003 | 7 | 0 |
| 2004 | 8 | 0 |
| 2005 | 7 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2009 | 5 | 0 |
| 2010 | 5 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 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 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? (6)
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 |
|---|---|---|---|
| * | K121874 | G7 Acetabular SystemSummary page 4…ncemented prosthesis. 21 CFR §888.3358, product code LPH Classification Class II, Orthopedic / 87 and Panel: Predicate G7 Acetabular System, K121874, K140669, K142882 (Biomet) Devices: Trinity Acetabular System, K093472, K110087, K123705, K111481 (Corin) Refe… | 2012 |
| * | K140669 | G7 Osseoti Acetublar ShellsSummary page 4…prosthesis. 21 CFR §888.3358, product code LPH Classification Class II, Orthopedic / 87 and Panel: Predicate G7 Acetabular System, K121874, K140669, K142882 (Biomet) Devices: Trinity Acetabular System, K093472, K110087, K123705, K111481 (Corin) Reference… | 2014 |
| * | K142882 | G7 Freedom and Offset Liners, Freedom Head, Size 32Summary page 4…prosthesis. 21 CFR §888.3358, product code LPH Classification Class II, Orthopedic / 87 and Panel: Predicate G7 Acetabular System, K121874, K140669, K142882 (Biomet) Devices: Trinity Acetabular System, K093472, K110087, K123705, K111481 (Corin) Reference EXp… | 2015 |
| * | K093472 | Trinity Acetabular SystemSummary page 4…Class II, Orthopedic / 87 and Panel: Predicate G7 Acetabular System, K121874, K140669, K142882 (Biomet) Devices: Trinity Acetabular System, K093472, K110087, K123705, K111481 (Corin) Reference EXp highly crosslinked Vitamin E UHMWPE acetabular shell liners, K094035 De… | 2010 |
| * | K110087 | Corin Trinity Acetbular System with Hxlpe LinersSummary page 4…II, Orthopedic / 87 and Panel: Predicate G7 Acetabular System, K121874, K140669, K142882 (Biomet) Devices: Trinity Acetabular System, K093472, K110087, K123705, K111481 (Corin) Reference EXp highly crosslinked Vitamin E UHMWPE acetabular shell liners, K094035 Devices:… | 2011 |
| * | K123705 | Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsSummary page 4…opedic / 87 and Panel: Predicate G7 Acetabular System, K121874, K140669, K142882 (Biomet) Devices: Trinity Acetabular System, K093472, K110087, K123705, K111481 (Corin) Reference EXp highly crosslinked Vitamin E UHMWPE acetabular shell liners, K094035 Devices: (S… | 2013 |
| † | K094035 | Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MM | 2011 |
| † | K112898 | Delta TT Cups, Delta TT Liners, Bone Screws | 2012 |
| † | K122873 | Vasopouse Deep Vein Thrombosis Compression Device Model Ipcs, Model SQS | 2013 |
| † | K840643 | Harris-Galante Porous Total Hip Sys | 1984 |
| † | K901364 | HGP II Total Hip Femeral Stem | 1990 |
| † | K912654 | Omnifit Epf Dual Geometry Acetabular Cup | 1991 |
| † | K911728 | Omnifit (R) Epf Dual Geomtry/Radius/Thread Acetab C | 1991 |
| † | K920831 | Pca Total Hip System (Cementless Use) | 1992 |
| † | K864857 | Opti-Fix Acetabular Component | 1987 |
| † | K942966 | Aml Trilock Replacement Liner System | 1994 |
| † | K943302 | Aml Tri-Lock Replacement Liner System | 1994 |
| † | K862702 | Tri-Lock II Titanium Acetabulum Prosthesis | 1986 |
| † | K935206 | Kirschner Integrity Acetabular Cup Modification | 1994 |
| † | K940486 | Digene DCR-1 Luminometer | 1995 |
| † | K121297 | Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series… | 2012 |
| † | K171273 | LINK® BiMobile (TM) Dual Mobility System | 2018 |
| † | K112802 | Pipeline Total Hip System | 2012 |
What descends from it? (8)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192559 | Acetabular Bone Screws (for MobileLink Acetabular Cup System) | 2019 | 4 |
| K190535 | BiMobile Dual Mobility System - E-Dur Inserts | 2019 | 3 |
| K241636 | MobileLink Acetabular Cup System - Line Extension (Multiple) | 2024 | 2 |
| K200607 | LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters | 2021 | 1 |
| K261009 | MobileLink Acetabular Cup System – 40mm ID Inserts (various) | 2026 | 0 |
| K222066 | LINK MobileLink Acetabular Cup System | 2023 | 0 |
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 38 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 42 of the 170 ancestors have a recall of any class.
- Of its descendants, K192559 (Waldemar Link GmbH & Co. KG, 2019) has gone furthest, with 4 descendants of its own.
- 10 other devices also cite its predicate K121874.
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. 2019, 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 patients with 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182321 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182321: 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/K182321
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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