# K110135: Polarcup Dual Mobility System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Oct 14, 2011 after 269 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: 3 generations back to K991990 (1999). 4 ancestors in all.
14 later devices descend from it; 7 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070278: Polarcup Dual Mobility System, Plus Orthopedics AG (2007) Summary page 1.
- K083116: Versafit Cup Double Mobility System, Medacta International S.A. (2009) Summary page 1.

## Most influential descendants
- K171934: Birmingham Hip (BH) Dual Mobility Insert (2017), 9 descendants of its own
- K191002: OR3O Dual Mobility System (2019), 5 descendants of its own
- K122244: Polarcup Dual Mobility System (2012), 5 descendants of its own
- K220959: OR3O Dual Mobility System (2022), 3 descendants of its own
- K211176: Smith & Nephew Hip Systems (2022), 3 descendants of its own

## Indications for use
The POLARCUP0 Dual Mobility System is indicated for: * 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 fracture to hip joint The POLARCUP0 Dual Mobility System is intended for single use only and depending on its version is to be implanted either with or without bone cement.

Source page: https://510kreport.com/device/K110135
Methodology: https://510kreport.com/methodology