# K243162: World Liner

- Pathway: 510(k) (Special)
- Applicant: Signature Orthopaedics Pty, Ltd.
- Decided: Nov 25, 2024 after 56 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
Longest line of descent: 14 generations back to K931641 (1994). 233 ancestors in all.
No later device cites it as a predicate yet.
0 of 233 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201278: World Hip Stem, World Cup, World Liner, Signature Orthopaedics Pty, Ltd. (2020) Summary page 5.
- K241690: Logical Liner; World Liner; World Knee Patella, Signature Orthopaedics Pty, Ltd. (2024) Summary page 5.

## 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' World Cup components are intended for cementless fixation only.

Source page: https://510kreport.com/device/K243162
Methodology: https://510kreport.com/methodology