# K211567: BiMobile Instruments (for BiMobile Dual Mobility System)

- Pathway: 510(k) (Special)
- Applicant: Waldemar Link GmbH & Co. KG
- Decided: Jun 3, 2022 after 378 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: 15 generations back to K810258 (1981). 216 ancestors in all.
No later device cites it as a predicate yet.
0 of 216 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.
- K190535: BiMobile Dual Mobility System - E-Dur Inserts, Waldemar Link GmbH & Co. KG (2019) Summary page 4.

## Indications for use
The BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects of 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 coxarthrosis * 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/K211567
Methodology: https://510kreport.com/methodology