# K160159: Active-X Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Signature Orthopaedics Pty, Ltd.
- Decided: Sep 6, 2016 after 223 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: 2 generations back to K973412 (1997). 2 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021740: Total Knee Cemented, Semi-Constrained, Dj Orthopedics, LLC (2002) Summary page 4.

## Most influential descendants
- K190577: World Knee Total Knee Systems (2019), 5 descendants of its own
- 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

## 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. The Active-X Knee replacement system is indicated for cemented fixation with bone cement (PMMA) only.

Source page: https://510kreport.com/device/K160159
Methodology: https://510kreport.com/methodology