# K242375: OR3O Dual Mobility System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Oct 7, 2024 after 59 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: 10 generations back to K810258 (1981). 186 ancestors in all.
No later device cites it as a predicate yet.
0 of 186 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220959: OR3O Dual Mobility System, Smith & Nephew, Inc. (2022) Summary page 5.
- K191002: OR3O Dual Mobility System, Smith & Nephew, Inc. (2019) Summary page 5.
- K232667: OR3O Dual Mobility Liners, Smith & Nephew, Inc. (2023) Summary page 5.
- K211176: Smith & Nephew Hip Systems, Smith & Nephew, Inc. (2022) Summary page 5.

## Indications for use
The OR30 Dual Mobility System is intended for use in primary and revision total hip arthroplasty in skeletally mature patients. Indications Advanced degeneration of the hip joint as a result of degenerative, post-traumatic, or rheumatoid arthritis. Fracture or avascular necrosis of the femoral head. Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. All forms of osteoarthritis. Patients with hips at risk of dislocation. Femoral neck fracture or proximal hip joint fracture. The OR30 Dual Mobility System is intended for single use only. The modular OR30 Liners and Inserts are to be implanted without bone cement.

Source page: https://510kreport.com/device/K242375
Methodology: https://510kreport.com/methodology