U2 Total Knee System-PF+
FDA 510(k) K221705 · United Orthopedic Corporation
510(k) numberK221705
Submission
- Device name
- U2 Total Knee System-PF+
- Applicant
- United Orthopedic Corporation
Hsinchu City, TW - Received
- June 13, 2022
- Decision date
- February 28, 2023
- 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 |
| K253239 | Active-V Total Knee System; World Total Knee SystemMBH · Traditional | Signature Orthopaedics Pty, Ltd. | 12/23/2025SE |
| 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 |
More from Howmedica Osteonics Corp., Dba Stryker Orthopaedics
| 510(k) | Device | Decision |
|---|---|---|
| K253948 | Momentum Acetabular Cup SystemLZO · Traditional | 09/02/2026SE |
| K252725 | Stem Extension Line (U2 Total Knee SystemPSA Type)JWH · Special | 09/25/2025SE |
| K252303 | Stem Extension Line (USTAR II System)KRO · Special | 08/22/2025SE |
| K243656 | U2 Total Knee System PF+ Patella; USTAR II System PF+ PatellaMBH · Traditional | 07/31/2025SE |
| K242315 | Resolve Modular Revision Hip StemMEH · Traditional | 05/01/2025SE |
| K243466 | Conformity Stem Extension Line, #0LZO · Traditional | 01/06/2025SE |
| K243024 | Cellbrick Knee SpacerJWH · Traditional | 12/20/2024SE |
| K242249 | Conformity Stem Extension LineLZO · Special | 08/30/2024SE |
| K221149 | U-Motion II Acetabular System-Extension lineLZO · Traditional | 01/05/2023SE |
| K221675 | United U2 femoral head, 22mm delta ceramic headLPH · Special | 11/04/2022SE |
Questions and answers
When was U2 Total Knee System-PF+ cleared by the FDA?
U2 Total Knee System-PF+ (K221705) received a 510(k) decision of Substantially Equivalent on February 28, 2023, 260 days after the submission was received.
What is the product code of K221705?
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.