# K181530: World Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Signature Orthopaedics Pty, Ltd.
- Decided: Oct 24, 2018 after 135 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
No predicates in its family tree.
9 later devices descend from it; 5 cite it directly.
0 of 10 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 its predicate without a number.
- (no number) Signature Orthopaedics World Knee System: named in the summary without a submission number
- (no number) Signature Orthopaedics Genius Knee System: named in the summary without a submission number
- (no number) S&N Surgical Knee System: named in the summary without a submission number
- (no number) Total Knee System: named in the summary without a submission number
- (no number) Smith & Nephew Knee System: named in the summary without a submission 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
- K241690: Logical Liner; World Liner; World Knee Patella (2024), 2 descendants of its own
- K260063: GSPE Spacer (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. Signature Orthopaedics’ 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/K181530
Methodology: https://510kreport.com/methodology