Class Class II
Logical Liner; World Liner; World Knee Patella (K241690)
Description
Logical Liner; World Liner; World Knee Patella by Signature Orthopaedics Pty, Ltd., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241690
Clearance Date2024-08-01
Clearance TypeSpecial
Product CodeMEH
Regulation Number888.3353
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241690
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Logical Liner; World Liner; World Knee Patella (K241690) cites 6 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201278 | World Hip Stem, World Cup, World Liner | Signature Orthopaedics Pty, Ltd. | 2020 |
| K192071 | iNSitu Total Hip System | Theken Companies, LLC | 2019 |
| K181530 | World Total Knee System | Signature Orthopaedics Pty, Ltd. | 2018 |
| K180750 | World Knee System | Signature Orthopaedics Pty, Ltd. | 2018 |
| K153131 | Logical C-Series Acetabular Shell, Logical Constrained Line... | Signature Orthopaedics Pty, Ltd. | 2016 |
| K121297 | ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR... | Signature Orthopaedics Pty, Ltd. | 2012 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K252824 | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Odd... | Signature Orthopaedics Pty, Ltd. | 2026 |
| K243162 | World Liner | Signature Orthopaedics Pty, Ltd. | 2024 |
Trace the full predicate network for K241690
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.