# K220737: World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal Inserts (CR, PS and UC)

- Pathway: 510(k) (Special)
- Applicant: Signature Orthopaedics Pty, Ltd.
- Decided: Apr 11, 2022 after 28 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: 4 generations back to K971206 (1998). 14 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190577: World Knee Total Knee Systems, Signature Orthopaedics Pty, Ltd. (2019) Summary page 4.
- K181530: World Total Knee System, Signature Orthopaedics Pty, Ltd. (2018) Summary page 4.
- K180750: World Knee System, Signature Orthopaedics Pty, Ltd. (2018). Our reading of the summary gave K180570, FDA’s number for Silverlon Island Wound Dressing, Silverlon Wound Pad… (Argentum Medical, LLC). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Signature Orthopaedics World Knee Total Knee System”.

## 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 Orthopaedic's 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/K220737
Methodology: https://510kreport.com/methodology