# K252824: Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head

- Pathway: 510(k) (Traditional)
- Applicant: Signature Orthopaedics Pty, Ltd.
- Decided: Mar 12, 2026 after 188 days
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K931641 (1994). 260 ancestors in all.
No later device cites it as a predicate yet.
0 of 260 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001956: Trident All Poly Cup, Howmedica Osteonics Corp. (2000) Summary page 6.
- K191449: ZCA All-Poly Acetabular Cups, Zimmer, Inc. (2020) Summary page 6.
- K241690: Logical Liner; World Liner; World Knee Patella, Signature Orthopaedics Pty, Ltd. (2024) Summary page 6.
- K201278: World Hip Stem, World Cup, World Liner, Signature Orthopaedics Pty, Ltd. (2020) Summary page 7.
- K153131: Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner, Signature Orthopaedics Pty, Ltd. (2016) Summary page 7.
- K142882: G7 Freedom and Offset Liners, Freedom Head, Size 32, Biomet, Inc. (2015) Summary page 7.
- 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 7.

## Indications for use
Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: • Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis • Inflammatory joint disease including rheumatoid arthritis • Correction of functional deformity including congenital hip dysplasia • Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture • Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement Signature Orthopaedics’ Origin, Nebula, Aria, Remedy, Origin-NS, Pegasus, Spartan, World and Everglade Hip femoral stems, SignaSure Cementless Cups, Logical and World Acetabular Cups are intended for cementless fixation only. Signature Orthopaedics’ Evolve, Cemented TSI (both CoCr and HNSS variants), Origin Cemented femoral stems and SignaSure Cemented Cups are intended for cemented fixation only. Signature Orthopaedics’ SignaSure Logical/World Metal Insert is indicated for use with a cementless Signature Orthopaedics’ Logical/World Acetabular Cup to provide dual mobility articulation. Signature Orthopaedics' constrained liner components are indicated particularly for patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability. Signature Orthopaedics’ Evolve UniPolar Head and BiPolar Head are intended for hemi-hip 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/K252824
Methodology: https://510kreport.com/methodology