# K143184: Evolve UniPolar Head

- Pathway: 510(k) (Traditional)
- Applicant: Signature Orthopaedics Pty, Ltd.
- Decided: Mar 17, 2015 after 132 days
- Product code: KWL (Prosthesis, Hip, Hemi-, Femoral, Metal)
- Device class: 2
- Regulation: 21 CFR 888.3360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K941847 (1994). 203 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 204 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121297: Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series Acetabular Shell, Logical Acetabular, Signature Orthopaedics Pty, Ltd. (2012) Summary page 4.
- K133370: Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem, Evolve Distal Centralizer, Evolve CE, Signature Orthopaedics Pty Limited (2014) Summary page 4.
- K896580: Uni-Polar Head, Richards Medical Co., Inc. (1990) Summary page 4.
- K102172: Msa Hip System, Global Manufacturing Technology (2011) Summary page 4.

## Most influential descendants
- K201047: Fusion Taper System (2021), 0 descendants of its own

## Indications for use
Signature Orthopaedics’ Evolve UniPolar Head is intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head is 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/K143184
Methodology: https://510kreport.com/methodology