MBH
- 产品代码
- MBH
- 器械名称
- Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 888.3565
- FDA 专业组
- Orthopedic
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 属植入器械
- 该代码近三年的 510(k)
- 144 件
该代码近三年的 510(k)（24 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K253728 | 2026-08-21 | Microport Orthopedics, Inc. | EVOLUTION® AM BIOFOAM® Tibial System | |
| K251840 | 2026-05-28 | Zimmer, Inc. | Zimmer® Persona® Personalized Knee System | |
| K253189 | 2026-03-09 | Zimmer, Inc. | Persona the Personalized Knee System (Persona Porous | |
| K253328 | 2026-02-26 | Medacta International S.A. | GMK 3D Metal Tibial Tray Extension | |
| K253637 | 2026-02-18 | Howmedica Osteonics Corp., Dba Stryker | Triathlon® Total Knee System - Triathlon® X3® Medial | |
| K253239 | 2025-12-23 | Signature Orthopaedics Pty, Ltd. | Active-V Total Knee System; World Total Knee System | |
| K253161 | 2025-12-19 | Ortho Development Corp. | Balanced Knee System TriMax Porous Femoral Component | |
| K252777 | 2025-10-31 | Maxx Orthopedics, Inc. | Freedom Metaphyseal Cone Implants (Metaphyseal Cones | |
| K252044 | 2025-10-24 | Howmedica Osteonics Corp., Dba Stryker | Triathlon® Total Knee System - Triathlon® Gold Femor | |
| K243656 | 2025-07-31 | United Orthopedic Corporation | U2 Total Knee System PF+ Patella; USTAR II System | |
| K250980 | 2025-05-22 | Lima Corporate S.P.A. | Physica System (Physica CR Porous Femoral components | |
| K243768 | 2025-03-27 | Restor3D, Inc. | iTotal® Identity Cruciate Retaining 3DP Porous Knee | |
| K241597 | 2025-02-13 | Maxx Orthopedics, Inc. | Freedom® Total Knee System - Porous Tibial Base Plat | |
| K243293 | 2024-12-20 | Zimmer Biomet | Zimmer® Persona® Personalized Knee System | |
| K243615 | 2024-12-18 | Lima Corporate S.P.A. | Physica Porous Femoral Components | |
| K242543 | 2024-11-22 | Zimmer, Inc. | Persona the Personalized Knee System (Persona Ti-Nid | |
| K242412 | 2024-11-06 | Medisurge, LLC | Agility Symmetric Total Knee System | |
| K243247 | 2024-10-29 | Zimmer, Inc. | Persona the Personalized Knee System | |
| K240393 | 2024-10-03 | Exactech, Inc. | Exactech® TRULIANT® Knee System | |
| K240938 | 2024-06-27 | Optimotion Implants, LLC | The Optimotion Blue Plus Knee System | FDA |
| K240678 | 2024-06-18 | Depuy Ireland UC | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized | |
| K240299 | 2024-04-26 | Zimmer, Inc. | Persona the Personalized Knee System (Persona OsseoT | |
| K233507 | 2024-01-18 | Microport Orthopedics, Inc. | EVOLUTION® Tibial Cones | |
| K232303 | 2023-12-11 | Depuy Ireland UC | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized | FDA |
FDA 官方分类页： MBH
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。