Cleared Traditional

Active-V Total Knee System; World Total Knee System

K253239 · Signature Orthopaedics Pty, Ltd. · Orthopedic

Dec 2025

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K253239 is an FDA 510(k) clearance for the Active-V Total Knee System; World Total Knee System, a Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (Class II — Special Controls, product code MBH), submitted by Signature Orthopaedics Pty, Ltd. (Lane Cove W., AU). The FDA issued a Cleared decision on December 23, 2025, 85 days after receiving the submission on September 29, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number	K253239 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2025
Decision Date	December 23, 2025
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MBH — Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3565