# K070278: Polarcup Dual Mobility System

- Pathway: 510(k) (Traditional)
- Applicant: Plus Orthopedics AG
- Decided: Apr 16, 2007 after 77 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: 1 generation back to K991990 (1999). 1 ancestor in all.
78 later devices descend from it; 8 cite it directly.
0 of 80 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991990: Tri-Polar System, Biomet, Inc. (1999) Summary page 1.

## Most influential descendants
- K083116: Versafit Cup Double Mobility System (2009), 59 descendants of its own
- K111572: Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH (Metal-Back), Novae E TH Dual Mobility Acetabular Cup Model (2011), 27 descendants of its own
- K101336: E1 Avantage Head (2011), 24 descendants of its own
- K092265: Vesafitcup Double Mobility- Highcross Hxuhmwpe Liners (2010), 23 descendants of its own
- K110555: Arcomxl Active Articulation (2011), 22 descendants of its own

## Indications for use
The POLARCUP® Dual Mobility System is indicated for: All forms of osteoarthritis Dislocation risks Progressive loss of function of the hip joint as a result of a degenerative post-traumatic or inflammatory / rheumatic destruction of the joint Femoral head necrosis Proximal femoral fractures (especially femoral neck) Status following earlier operations such as osteosynthesis, intertrochanteric osteotomies, arthrodesis or failed joint replacement The POLARCUP® Dual Mobility System is intended for cemented or press-fit application with or without flanges and pegs for general use in skeletally mature individuals undergoing surgery for rehabilitating hip joints.

Source page: https://510kreport.com/device/K070278
Methodology: https://510kreport.com/methodology