# K243927: MobileLink Acetabular Cup System - inhouse coatings

- Pathway: 510(k) (Traditional)
- Applicant: Waldemar Link GmbH & Co. KG
- Decided: May 16, 2025 after 147 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: 16 generations back to K810258 (1981). 209 ancestors in all.
No later device cites it as a predicate yet.
0 of 209 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241636: MobileLink Acetabular Cup System - Line Extension (Multiple), Waldemar Link GmbH & Co. KG (2024) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K243927
Methodology: https://510kreport.com/methodology