# K192559: Acetabular Bone Screws (for MobileLink Acetabular Cup System)

- Pathway: 510(k) (Special)
- Applicant: Waldemar Link GmbH & Co. KG
- Decided: Dec 21, 2019 after 95 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: 14 generations back to K810258 (1981). 199 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 203 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.
- K121297: Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series Acetabular Shell, Logical Acetabular, Signature Orthopaedics Pty, Ltd. (2012) Summary page 4.

## Most influential descendants
- K241636: MobileLink Acetabular Cup System - Line Extension (Multiple) (2024), 2 descendants of its own
- 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
- K222066: LINK MobileLink Acetabular Cup System (2023), 0 descendants of its own

## Indications for use
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. 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/K192559
Methodology: https://510kreport.com/methodology