# K200854: DePuy PINNACLE Dual Mobility Liner

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Ireland UC
- Decided: Sep 11, 2020 after 164 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K010170 (2001). 4 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 12 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.

## Most influential descendants
- K231873: DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR Conditional (2024), 5 descendants of its own
- K251292: RECLAIM Monobloc Revision Femoral Stem (2025), 1 descendant of its own
- K243977: EMPHASYS Acetabular System (2025), 1 descendant of its own
- K260173: M-Vizion Femoral Revision System Extension (2026), 0 descendants of its own
- K252067: Velora Acetabular System (2025), 0 descendants of its own

## Indications for use
Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint (typically due to non inflammatory degenerative joint disease). 2. Failed previous hip surgery. 3. Dislocation risks. PINNACLE Dual Mobility Metal Liners and Porous-coated PINNACLE Acetabular Cups are intended for cementless applications.

Source page: https://510kreport.com/device/K200854
Methodology: https://510kreport.com/methodology