# K181744: BI-MENTUM dual mobility system

- Pathway: 510(k) (Traditional)
- Applicant: Serf
- Decided: Dec 11, 2018 after 162 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: 3 generations back to K991990 (1999). 4 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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 5.

## Most influential descendants
- K203532: BI-MENTUM™ ALTRX® Dual Mobility Liner (2021), 6 descendants of its own
- 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
- K223745: Novae® Dual Mobility System, Hype® Hip System (2023), 1 descendant of its own

## Indications for use
BI-MENTUM™ Dual Mobility System is indicated for total hip replacement, which includes: - 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 BI-MENTUM™ PressFit Cup, BI-MENTUM™ Plus Cup and BI-MENTUM™ Revision Cup are intended for press-fit use and BI-MENTUM™ Cemented Cup is indicated for cemented use.

Source page: https://510kreport.com/device/K181744
Methodology: https://510kreport.com/methodology