FDA 510(k)

U2 全膝系統 – PF+ 髌骨；USTAR II 系統 – PF+ 髌骨

K 號：K243656 · 2025-07-31

決定日期2025-07-31

產品代碼MBH

諮詢委員會或

決定相當於

器材摘要

U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella is the device name listed in this FDA 510(k) record. The listed applicant is United Orthopedic Corporation. It received FDA 510(k) clearance on 2025-07-31 under 510(k) number K243656. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella?

U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella is a medical device that received FDA 510(k) clearance on 2025-07-31. The listed applicant is United Orthopedic Corporation. The 510(k) number is K243656.

When did U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella receive FDA 510(k) clearance?

U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella received FDA 510(k) clearance on 2025-07-31, under 510(k) number K243656.

Who is the listed applicant for U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella?

FDA 510(k) 記錄中將 United Orthopedic Corporation 列為申請人。這並不單獨確立該設備製造商的身份。

What is the FDA product code for U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella?

The FDA product code for U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella is MBH.

其他以 United Orthopedic Corporation 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K253948動力骨盂杯系統 K252725樹突延伸線 (U2 全膝系統—PSA 型式)K252303樹突延伸線 (USTAR II 系統)K242315解決模組化修復股骨柄 K243466合規樹枝擴展線，#0 K243024細膠骨膝間隔

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相關器械（代碼：MBH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261275Unity全膝系統，Unity膝水泥無縫股骨Corin, Ltd.K261462LANDMARK 全膝系統Smith & Nephew, Inc.K253728EVOLUTION® AM BIOFOAM® 道骨系統Microport Orthopedics, Inc.K251840齊默® 佩森娜® 適合個人化膝關節系統Zimmer, Inc.K253189Persona 個人化膝關節系統（Persona 多孔等离子喷涂 PPS 髋骨）Zimmer, Inc.K253328GMK 3D金屬胫骨托延伸器Medacta International S.A.

官方來源

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