# K222066: LINK MobileLink Acetabular Cup System

- Pathway: 510(k) (Traditional)
- Applicant: Waldemar Link GmbH & Co. KG
- Decided: Apr 14, 2023 after 275 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K810258 (1981). 245 ancestors in all.
No later device cites it as a predicate yet.
0 of 245 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182321: MobileLink Acetabular Cup System, Waldemar Link GmbH & Co. KG (2019) Summary page 4.
- K192559: Acetabular Bone Screws (for MobileLink Acetabular Cup System), Waldemar Link GmbH & Co. KG (2019) Summary page 4.
- K200607: LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters, Waldemar Link GmbH & Co. KG (2021) Summary page 4.
- K140669: G7 Osseoti Acetublar Shells, Biomet, Inc. (2014) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K222066
Methodology: https://510kreport.com/methodology