# K220959: OR3O Dual Mobility System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Aug 18, 2022 after 139 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: 7 generations back to K955033 (1996). 55 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191002: OR3O Dual Mobility System, Smith & Nephew, Inc. (2019) Summary page 4.
- K110135: Polarcup Dual Mobility System, Smith & Nephew, Inc. (2011) Summary page 4.
- K071160: Reflection, Tandem Unipolar, Smith & Nephew, Inc. (2007) Summary page 4.
- K932755: Reflection Acetabular Component, Smith & Nephew Richards, Inc. (1994) Summary page 4.
- K171934: Birmingham Hip (BH) Dual Mobility Insert, Smith & Nephew, Inc. (2017) Summary page 4.

## Most influential descendants
- K232667: OR3O Dual Mobility Liners (2023), 1 descendant of its own
- K253948: Momentum Acetabular Cup System (2026), 0 descendants of its own
- K242375: OR3O Dual Mobility System (2024), 0 descendants of its own

## Indications for use
Intended Use The OR3O 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 OR3O Dual Mobility System is intended for single use only. The modular OR3O Liners and Inserts are to be implanted without bone cement. Mating components may be indicated for use without bone cement.

Source page: https://510kreport.com/device/K220959
Methodology: https://510kreport.com/methodology