# K253239: Active-V Total Knee System; World Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Signature Orthopaedics Pty, Ltd.
- Decided: Dec 23, 2025 after 85 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K810258 (1981). 55 ancestors in all.
No later device cites it as a predicate yet.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181530: World Total Knee System, Signature Orthopaedics Pty, Ltd. (2018) Summary page 5.
- K223062: World Total Knee System, Signature Orthopaedics Pty, Ltd. (2022) Summary page 5.
- K222380: TriVerse Total Knee Replacement System, Signature Orthopaedics Pty, Ltd. (2022) Summary page 5.
- K220737: World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal Inserts (CR, PS and UC), Signature Orthopaedics Pty, Ltd. (2022) Summary page 6.

## 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 needs 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 device have failed Fractures that are unmanageable using other techniques Signature Orthopaedics' Active-V/World Total Knee components may be intended for cemented and cementless use.

Source page: https://510kreport.com/device/K253239
Methodology: https://510kreport.com/methodology