# K181338: Imboki Knee Instrument System

- Pathway: 510(k) (Traditional)
- Applicant: Signature Orthopaedics Pty, Ltd.
- Decided: Jan 17, 2019 after 241 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: 1 generation back to K180750 (2018). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
Signature Orthopaedics Imboki Knee Instrument System are accessory devices intended to be used to assist the implantation of Signature Orthopaedics’ World Total Knee System and its cleared 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.

Source page: https://510kreport.com/device/K181338
Methodology: https://510kreport.com/methodology