# K241636: MobileLink Acetabular Cup System - Line Extension (Multiple)

- Pathway: 510(k) (Traditional)
- Applicant: Waldemar Link GmbH & Co. KG
- Decided: Nov 8, 2024 after 155 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: 15 generations back to K810258 (1981). 208 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 210 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 5.
- K062148: Depuy Pinnacle Altrx Acetabular Cup Liner, DePuy Orthopaedics, Inc. (2006) Summary page 5.
- K061067: Trabecular Metal Acetabular Augments, Zimmer Trabecular (2006) Summary page 5.
- K042871: Trabecular Metal Acetabular Augments, Models 4894-XXX-YY, 02-212-105XX3, 02-212-205XX3, 02-212-305XX3, Zimmer Trabecular (2004) Summary page 5.
- K102019: Restoration Acetabular Wedge Augments, Howmedica Osteonics (2011) Summary page 5.
- K192559: Acetabular Bone Screws (for MobileLink Acetabular Cup System), Waldemar Link GmbH & Co. KG (2019) Summary page 5.
- K021891: Zimmer Trabecular Metal Modular Acetabular System, Zimmer, Inc. (2002) Summary page 5.
- K934765: Trilogy Acetabular System, Zimmer, Inc. (1994) Summary page 5.

## Most influential descendants
- K261009: MobileLink Acetabular Cup System – 40mm ID Inserts (various) (2026), 0 descendants of its own
- K243927: MobileLink Acetabular Cup System - inhouse coatings (2025), 0 descendants of its own

## Indications for use
The MobileLink Acetabular Cup System is indicated for patients with mobility-limiting diseases, fractures, or defects of the hip joint or proximal femur 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 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. The MobileLink Acetabular Shells are intended for cementless fixation. The TrabeculLink Augments are intended for cementless fixation to the bone and for cemented fixation to the mating shell.

Source page: https://510kreport.com/device/K241636
Methodology: https://510kreport.com/methodology