# K122244: Polarcup Dual Mobility System

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Aug 23, 2012 after 27 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: 5 generations back to K932481 (1994). 10 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120211: SL-Plus Standard and Lateral Femoral Stem with TI/HA Coating, Smith & Nephew, Inc. (2012) Summary page 2.
- K110135: Polarcup Dual Mobility System, Smith & Nephew, Inc. (2011) Summary page 2.

## Most influential descendants
- K211176: Smith & Nephew Hip Systems (2022), 3 descendants of its own
- K240783: Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems (2024), 0 descendants of its own
- K242375: OR3O Dual Mobility System (2024), 0 descendants of its own
- K231448: TANDEM Hip System (2023), 0 descendants of its own
- K181491: Delta Dual Mobility System (2019), 0 descendants of its own

## Indications for use
The POLARCUP 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 titanium plasma and titanium/HA coated implants are intended to be implanted without bone cement. The uncoated implant is intended to be implanted with bone cement. The POLARCUP Dual Mobility System is intended for single use only.

Source page: https://510kreport.com/device/K122244
Methodology: https://510kreport.com/methodology