# K163081: 40-42mm BiPolar Head and 22mm Femoral Head

- Pathway: 510(k) (Traditional)
- Applicant: Signature Orthopaedics Pty, Ltd.
- Decided: Jan 29, 2018 after 452 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 2 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K100002: Signature Orthopaedics Bipolar Head. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K121210: Signature Orthopaedics Femoral Head. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K191708: Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head (2020), 0 descendants of its own

## Indications for use
Signature Orthopaedics’ Evolve UniPolar Head and BiPolar Head are intended for hemihip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head and BiPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as: • Acute femoral head or neck fracture • Fracture dislocation of the hip • Avascular necrosis of the femoral head • Non-union of femoral neck fractures • Certain high subcapital and femoral neck fractures in the elderly • Degenerative arthritis involving only the femoral head

Source page: https://510kreport.com/device/K163081
Methodology: https://510kreport.com/methodology