# K200709: Kyocera Bipolar Hip System

- Pathway: 510(k) (Special)
- Applicant: Kyocera Medical Technologies, Inc.
- Decided: Apr 17, 2020 after 30 days
- Product code: KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3390
- 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 K941847 (1994). 58 ancestors in all.
No later device cites it as a predicate yet.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131354: Renovis Bipolar Hip System, Renovis Surgical Technologies, LLC (2013) Summary page 4.

## Indications for use
1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2. Rheumatoid arthritis; 3. Correction of functional deformity; 4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques Qualifier: The Bipolar Head is for use in conjunction with KMTI femoral heads and femoral stems. In addition: -The KYOCERA Medical Corporation (“KYOCERA”) Initia Total Hip System 28mm CoCr and 28mm BIOCERAM AZUL femoral head and Initia femoral stems can be used with the KMTI 28mm ID Bipolar Head. -The KYOCERA Initia Total Hip System femoral stem can be used with the KMTI 22mm CoCr femoral head and KMTI 22mm ID Bipolar Head. The Bipolar Head is for uncemented use only. Bipolar outer heads are not for use with acetabular shells and liners.

Source page: https://510kreport.com/device/K200709
Methodology: https://510kreport.com/methodology