# K190535: BiMobile Dual Mobility System - E-Dur Inserts

- Pathway: 510(k) (Traditional)
- Applicant: Waldemar Link GmbH & Co. KG
- Decided: Aug 6, 2019 after 155 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K810258 (1981). 215 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 218 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171273: LINK® BiMobile (TM) Dual Mobility System, Waldemar Link GmbH & Co. KG (2018) Summary page 4.
- K170359: Trinity™ Dual Mobility System, Corin U.S.A. Limited (2017) Summary page 4.
- K094035: Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MM, Stelkast Company (2011) Summary page 4.
- K182321: MobileLink Acetabular Cup System, Waldemar Link GmbH & Co. KG (2019). Cleared while this submission was under review Summary page 4.

## Most influential descendants
- K200607: LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters (2021), 1 descendant of its own
- K222066: LINK MobileLink Acetabular Cup System (2023), 0 descendants of its own
- K211567: BiMobile Instruments (for BiMobile Dual Mobility System) (2022), 0 descendants of its own

## Recalls of this device
- Jan 22, 2024 · Class II · Z-1219-2024: Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery

## Indications for use
The BiMobile Dual Mobility 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. The BiMobile Dual Mobility System is indicated for the following conditions: • 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 • Dislocation risks The device is intended for cemented and cementless use.

Source page: https://510kreport.com/device/K190535
Methodology: https://510kreport.com/methodology