# K182321: MobileLink Acetabular Cup System

- Pathway: 510(k) (Traditional)
- Applicant: Waldemar Link GmbH & Co. KG
- Decided: May 24, 2019 after 270 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K810258 (1981). 171 ancestors in all.
8 later devices descend from it; 6 cite it directly.
0 of 179 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121874: G7 Acetabular System, Biomet Manufacturing Corp (2012) Summary page 4.
- K140669: G7 Osseoti Acetublar Shells, Biomet, Inc. (2014) Summary page 4.
- K142882: G7 Freedom and Offset Liners, Freedom Head, Size 32, Biomet, Inc. (2015) Summary page 4.
- K093472: Trinity Acetabular System, Corin USA (2010) Summary page 4.
- K110087: Corin Trinity Acetbular System with Hxlpe Liners, Corin USA (2011) Summary page 4.
- K123705: Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular Shells, Corin USA (2013) Summary page 4.

## Most influential descendants
- K192559: Acetabular Bone Screws (for MobileLink Acetabular Cup System) (2019), 4 descendants of its own
- K190535: BiMobile Dual Mobility System - E-Dur Inserts (2019), 3 descendants of its own
- K241636: MobileLink Acetabular Cup System - Line Extension (Multiple) (2024), 2 descendants of its own
- K200607: LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters (2021), 1 descendant of its own
- K261009: MobileLink Acetabular Cup System – 40mm ID Inserts (various) (2026), 0 descendants of its own

## Indications for use
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

Source page: https://510kreport.com/device/K182321
Methodology: https://510kreport.com/methodology