# K191826: KeYi Total Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Keyi Medical Device Technology Co., Ltd.
- Decided: May 14, 2020 after 311 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: 8 generations back to K930712 (1993). 101 ancestors in all.
No later device cites it as a predicate yet.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111472: Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip System, Acetabular Shell, Helicon, Tgm Medical (2011) Summary page 4.
- K980513: Articul/Eze Femoral Heads, DePuy Orthopaedics, Inc. (1998) Summary page 4.
- K961186: Depuy Duraloc Cementless Acetabular Cup System, Depuy, Inc. (1996) Summary page 4.
- K001991: Titan Porocoat Hip Prosthesis, DePuy Orthopaedics, Inc. (2000) Summary page 4.
- K983491: Depuy Duraloc Acetabular Cup System-Enduron Liner, DePuy Orthopaedics, Inc. (1998) Summary page 4.

## Indications for use
The KeYi Total Hip System is designed for total hip arthroplasty. The indications for use are: a. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. b. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures. c. Proximal femoral fractures. d. Avascular necrosis of the femoral head. e. Non-union of proximal femoral neck fractures. f. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities. The KeYi femoral stems are indicated for cementless use. The KeYi acetabular shells are indicated for cemented or cementless use.

Source page: https://510kreport.com/device/K191826
Methodology: https://510kreport.com/methodology