Active-V Total Knee System; World Total Knee System
FDA 510(k) K253239 · Signature Orthopaedics Pty, Ltd.
510(k) numberK253239
Submission
- Device name
- Active-V Total Knee System; World Total Knee System
- Applicant
- Signature Orthopaedics Pty, Ltd.
Lane Cove West, AU - Received
- September 29, 2025
- Decision date
- December 23, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBH – Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3565
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MBH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261462 | LANDMARK Total Knee SystemMBH · Traditional | Smith & Nephew, Inc. | 09/08/2026SE |
| K253728 | EVOLUTION® AM BIOFOAM® Tibial SystemMBH · Traditional | Microport Orthopedics, Inc. | 08/21/2026SE |
| K251840 | Zimmer® Persona® Personalized Knee SystemMBH · Traditional | Zimmer, Inc. | 05/28/2026SE |
| K253189 | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)MBH · Traditional | Zimmer, Inc. | 03/09/2026SE |
| K253328 | GMK 3D Metal Tibial Tray ExtensionMBH · Traditional | Medacta International S.A. | 02/26/2026SE |
| K253637 | Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertMBH · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 02/18/2026SE |
| K253161 | Balanced Knee System TriMax Porous Femoral ComponentsMBH · Traditional | Ortho Development Corp. | 12/19/2025SE |
| K252777 | Freedom Metaphyseal Cone Implants (Metaphyseal Cones)MBH · Traditional | Maxx Orthopedics, Inc. | 10/31/2025SE |
| K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsMBH · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 10/24/2025SE |
| K243656 | U2 Total Knee System PF+ Patella; USTAR II System PF+ PatellaMBH · Traditional | United Orthopedic Corporation | 07/31/2025SE |
More from United Orthopedic Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K252824 | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadJDI · Traditional | 03/12/2026SE |
| K251771 | Cambridge Partial KneeHSX · Traditional | 12/16/2025SE |
| K243021 | Longboard Revision Hip StemLZO · Traditional | 08/07/2025SE |
| K242674 | Freedom Posterior Cervical ScrewsNKG · Traditional | 05/13/2025SE |
| K242477 | Shoulder Soft Tissue AnchorsMBI · Traditional | 05/12/2025SE |
| K243043 | Origin Cemented Hip StemLZO · Traditional | 05/02/2025SE |
| K243029 | Origin TT StemLZO · Traditional | 03/11/2025SE |
| K243162 | World LinerMEH · Special | 11/25/2024SE |
| K240683 | Rx Knee SystemJWH · Traditional | 09/11/2024SE |
| K241690 | Logical Liner; World Liner; World Knee PatellaMEH · Special | 08/01/2024SE |
Questions and answers
When was Active-V Total Knee System; World Total Knee System cleared by the FDA?
Active-V Total Knee System; World Total Knee System (K253239) received a 510(k) decision of Substantially Equivalent on December 23, 2025, 85 days after the submission was received.
What is the product code of K253239?
The FDA product code is MBH – Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3565.