# K171273: LINK® BiMobile (TM) Dual Mobility System

- Pathway: 510(k) (Traditional)
- Applicant: Waldemar Link GmbH & Co. KG
- Decided: Jan 19, 2018 after 263 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K955033 (1996). 53 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072020: Restoration Adm System, Howmedica Osteonics Corp. (2007) Summary page 4.
- K093472: Trinity Acetabular System, Corin USA (2010) Summary page 4.
- K111572: Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH (Metal-Back), Novae E TH Dual Mobility Acetabular Cup Model, Serf (2011) Summary page 4.

## Most influential descendants
- K190535: BiMobile Dual Mobility System - E-Dur Inserts (2019), 3 descendants of its own
- 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
- Dec 4, 2018 · Class II · Z-0728-2019: The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records.
- Dec 4, 2018 · Class II · Z-0729-2019: The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records.

## Indications for use
The LINK® BiMobile™ Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The LINK® BiMobile™ Dual Mobility System is indicated for the following conditions: • Primary and secondary coxarthrosis • Osteoarthritis • Necrosis of the femoral head • Femoral neck fractures • Revision after implant loosening • Acetabular dysplasia The device is intended for cemented and cementless use.

Source page: https://510kreport.com/device/K171273
Methodology: https://510kreport.com/methodology