# K223062: World Total Knee System

- Pathway: 510(k) (Special)
- Applicant: Signature Orthopaedics Pty, Ltd.
- Decided: Nov 4, 2022 after 35 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 3 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K093017: Stellar 300, Larsen & Toubro Limited (2010). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K082636: TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3T, Quality Electrodynamics (2008). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K080611: Mesa Spinal System, K2m, Inc. (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- 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 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. Please verify whether the particular component is intended for cemented or cementless use by checking the package label.

Source page: https://510kreport.com/device/K223062
Methodology: https://510kreport.com/methodology