# K241690: Logical Liner; World Liner; World Knee Patella

- Pathway: 510(k) (Special)
- Applicant: Signature Orthopaedics Pty, Ltd.
- Decided: Aug 1, 2024 after 50 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: 13 generations back to K931641 (1994). 232 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 234 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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 5.
- 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 5.
- K201278: World Hip Stem, World Cup, World Liner, Signature Orthopaedics Pty, Ltd. (2020) Summary page 5.
- K180750: World Knee System, Signature Orthopaedics Pty, Ltd. (2018) Summary page 5.
- K181530: World Total Knee System, Signature Orthopaedics Pty, Ltd. (2018) Summary page 5.
- K192071: iNSitu Total Hip System, Theken Companies, LLC (2019) Summary page 5.

## Most influential descendants
- 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
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 intended 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 Patients should be skeletally mature to receive a knee replacement. Patients should have adequate bone stock and size to support and accept the prosthesis. The patient’s need for knee replacement should be due to one or more of the following conditions: - Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis. - Inflammatory degenerative joint disease including rheumatoid arthritis. - Functional deformity such as varus, valgus or flexion deformities. - Revision procedures where other treatments or devices have failed. - Fractures that are unmanageable using other techniques. Signature Orthopaedics’ World Knee replacement components may be intended for cemented or cementless use.

Source page: https://510kreport.com/device/K241690
Methodology: https://510kreport.com/methodology