# K200607: LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters

- Pathway: 510(k) (Traditional)
- Applicant: Waldemar Link GmbH & Co. KG
- Decided: May 28, 2021 after 445 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- 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: 15 generations back to K810258 (1981). 216 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 217 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103233: Modular Dual Mobility Liner, X3 Acetabular Insert, Howmedica Osteonics Corp. (2011) Summary page 4.
- K150522: G7 Dual Mobility System, Biomet, Inc. (2015) Summary page 4.
- K190535: BiMobile Dual Mobility System - E-Dur Inserts, Waldemar Link GmbH & Co. KG (2019) Summary page 4.
- K182321: MobileLink Acetabular Cup System, Waldemar Link GmbH & Co. KG (2019) Summary page 4.

## Most influential descendants
- K222066: LINK MobileLink Acetabular Cup System (2023), 0 descendants of its own

## Recalls of this device
- Jul 14, 2023 · Class II · Z-2641-2023: Product is labeled with incorrect offset.

## Indications for use
General indications: The MobileLink(R) Acetabular Cup System is indicated for patients with mobility-limiting diseases, fractures or defects 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(R) Dual Mobility Insert is additionally indicated for: 7) Dislocation risks The MobileLink(R) Acetabular Shells are intended for cementless fixation.

Source page: https://510kreport.com/device/K200607
Methodology: https://510kreport.com/methodology