# K170613: Genius Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Signature Orthopaedics Pty, Ltd.
- Decided: Jul 17, 2017 after 138 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## 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

## Recalls of this device
- Dec 10, 2018 · Class II · Z-0833-2019: Product mix up
- Dec 10, 2018 · Class II · Z-0834-2019: Product mix up

## Indications for use
The Genius Knee System is intended for use in total knee replacement. Patients should be skeletally mature and have adequate bone stock and soft tissue support and accept the prosthesis. The patient's need for replacement should be due to one or more of the following conditions: • Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, 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 Genius Knee replacement system is indicated for cemented fixation with cement (PMMA) only.

Source page: https://510kreport.com/device/K170613
Methodology: https://510kreport.com/methodology