# K240683: Rx Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Signature Orthopaedics Pty, Ltd.
- Decided: Sep 11, 2024 after 183 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: 7 generations back to K936159 (1995). 47 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183017: Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer, Osteoremedies, LLC (2019) Summary page 5.
- K160700: ATTUNE Revision Knee System, Depuy (Ireland) (2016) Summary page 5.
- K181530: World Total Knee System, Signature Orthopaedics Pty, Ltd. (2018) Summary page 5.
- K220737: World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal Inserts (CR, PS and UC), Signature Orthopaedics Pty, Ltd. (2022) Summary page 5.
- K223062: World Total Knee System, Signature Orthopaedics Pty, Ltd. (2022) Summary page 5.

## Most influential descendants
- K260063: GSPE Spacer (2026), 0 descendants of its own
- K261734: Klassic Infection Spacer System (2026), 0 descendants of its own

## Indications for use
The patient should be skeletally mature to receive a knee replacement. The Rx Knee System is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in patients undergoing a two-stage procedure due to a septic process and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organism(s). The device is intended for use in conjunction with systemic antimicrobial therapy (standard treatment approach to an infection). The device is intended for use with the gentamicin-loaded cement, Palacos@ G. The Rx Knee System is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion etc.). The device is only indicated for patients who will consistently use traditional mobility assist devices (e.g., crutches, walkers, canes) throughout the implantation period, allowing basic joint mobility.

Source page: https://510kreport.com/device/K240683
Methodology: https://510kreport.com/methodology