# K201278: World Hip Stem, World Cup, World Liner

- Pathway: 510(k) (Traditional)
- Applicant: Signature Orthopaedics Pty, Ltd.
- Decided: Sep 21, 2020 after 131 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 12 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K191608: Impress Angiographic Catheter, Merit Medical Systems, Inc. (2019). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K199895: Zimmer Biomet G7 Acetabular Cup System. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K199810: Signature Orthopaedics Legacy G-PE Acetabular Cup Liner. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K083131: Medos Hilite Reservoir, Model: 4030, Gish Biomedical, Inc. (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K090909: C-Qur V -Patch Mesh, Atrium Medical Corp. (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K181290: Fusion Bx 2.0, Focal Healthcare, Inc. (2018). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K183878: World Cup and World Liner. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K182828: Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer, Surgical Instrument Service and Savings, Inc. (2019). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K183373: Bonebridge, Med-El Elektromedizinische Geraete GmbH (2019). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K176767: Signature Orthopaedics’ Legacy Acetabular Cup. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K191387: ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube, Envizion Medical, Ltd. (2019). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K190226: Signature Orthopaedics’ Legacy G-PE Liners. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K241690: Logical Liner; World Liner; World Knee Patella (2024), 2 descendants of its own
- K252824: Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head (2026), 0 descendants of its own
- K243162: World Liner (2024), 0 descendants of its own

## Indications for use
The Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. The 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 or post-traumatic 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, reconstructive, hemiarthroplasty, surface replacement, or total replacement Signature Orthopaedics’ Origin, Aria, Remedy, TSI, Pegasus, Sport, World Hip femoral stems, Signature Cementless Cups, and Signature Cementless Cups, Wical and World Acetabular Cups are intended for cementless fixation only. Signature Orthopaedics’ Evoke, Cemented TSI (with CCDR variants), Cemented Origin femoral stems and Signature Cemented Cups are intended for cemented fixation only. Signature Orthopaedics’ Signature Insert is indicated for use with a cementless Signature Orthopaedics’ Wical 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 Bipolar Head and Bipolar Head are intended for hemi-hip arthroplasty only, where the natural acetabulum is not required to be replaced. The Evolve Bipolar Head and Bipolar Head are indicated for use for bone fractures or pathologies involving the femoral head/neck 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 femoral neck fractures in the elderly • Degenerative arthritis involving only the femoral head

Source page: https://510kreport.com/device/K201278
Methodology: https://510kreport.com/methodology