# K203532: BI-MENTUM™ ALTRX® Dual Mobility Liner

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Ireland UC
- Decided: Apr 28, 2021 after 147 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: 4 generations back to K991990 (1999). 5 ancestors in all.
6 later devices descend from it; 1 cites 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)
- K181744: BI-MENTUM dual mobility system, Serf (2018) Summary page 6.

## 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
BI-MENTUMTm ALTRX@ Dual Mobility System is indicated for total hip replacement in the following conditions: - Osteoarthritis - Femoral neck fracture - Dislocation risk - Osteonecrosis of the femoral head - Revision procedures where other treatments or devices have failed and if bone reconstruction so permits

Source page: https://510kreport.com/device/K203532
Methodology: https://510kreport.com/methodology