# K190577: World Knee Total Knee Systems

- Pathway: 510(k) (Traditional)
- Applicant: Signature Orthopaedics Pty, Ltd.
- Decided: Nov 27, 2019 after 266 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K971206 (1998). 13 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180750: World Knee System, Signature Orthopaedics Pty, Ltd. (2018) Summary page 4.
- K181530: World Total Knee System, Signature Orthopaedics Pty, Ltd. (2018) Summary page 4.
- K170613: Genius Total Knee System, Signature Orthopaedics Pty, Ltd. (2017) Summary page 4.
- K160159: Active-X Total Knee System, Signature Orthopaedics Pty, Ltd. (2016) Summary page 4.
- K030612: Genesis II Total Knee System, Smith & Nephew, Inc. (2003) Summary page 4.
- K032683: Genesis II Porous Plus HA Knee System, Smith & Nephew, Inc. (2003) Summary page 4.

## Most influential descendants
- K220737: World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal Inserts (CR, PS and UC) (2022), 4 descendants of its own
- K240683: Rx Knee System (2024), 2 descendants of its own
- K260063: GSPE Spacer (2026), 0 descendants of its own
- K261734: Klassic Infection Spacer System (2026), 0 descendants of its own
- K253239: Active-V Total Knee System; World Total Knee System (2025), 0 descendants of its own

## Indications for use
The patient should be skeletally mature to receive a World Knee replacement system. 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. The World Knee replacement system is indicated for cemented fixation with bone cement (PMMA) only.

Source page: https://510kreport.com/device/K190577
Methodology: https://510kreport.com/methodology