# K131354: Renovis Bipolar Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Renovis Surgical Technologies, LLC
- Decided: Sep 19, 2013 after 132 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: 7 generations back to K941847 (1994). 57 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060707: Aesculap Bipolar Acetabular Cup, Aesculap, Inc. (2006) Summary page 1.
- K972961: Stelkast Bipolar System, Stelkast Company (1997) Summary page 1.

## Most influential descendants
- K200709: Kyocera Bipolar Hip System (2020), 0 descendants of its own

## Indications for use
Non-inflammatory degenerative joint disease including ostcoarthritis and avascular necrosis Rheumatoid arthritis Correction of functional deformity Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other technique

Source page: https://510kreport.com/device/K131354
Methodology: https://510kreport.com/methodology