BHR modular head system - PMDA ID 371113_22300BZX00021000_A_02_03
Access comprehensive regulatory information for BHR modular head system (BHR モジュラー ヘッド システム) in the Japan medical device market through Pure Global AI's free bilingual database. This MD medical device is registered under PMDA ID 371113_22300BZX00021000_A_02_03 and manufactured by Smith & Nephew Co., Ltd.. The device information was last updated on July 25, 2022.
This page provides complete registration details including device class (B0400), classification (total hip prosthesis / 全人工股関節), manufacturer information (English and Japanese), intended use, and regulatory compliance data from the official Japan PMDA medical device database. Pure Global AI offers free bilingual access to Japan's complete medical device registry, helping global MedTech companies navigate PMDA regulations efficiently.
This product is an implant for joint function reconstruction used on the femoral side and acetabular side in total hip replacement surgery in orthopedic surgery. Instead of using inserts on the sliding surface, joint movement is assisted by sliding by combining metal implants. Do not reuse because it is a disposable product. *Indicated: Non-inflammatory arthritis such as osteoarthritis, traumatic arthritis, oligohemonecrosis (osteoarthritis), inflammatory arthritis such as rheumatoid arthritis, femoral neck fracture, etc.
本品は、整形外科において全人工股関節置換術で大腿骨側と寛骨臼側に用いる関節機能再建のためのインプラントである。摺動面にインサートを使用せず、金属製のインプラント同士を組み合わせて摺動させることで関節動を補助する。ディスポーザブル製品であるため再使用しない。*適応患者変形性関節症、外傷性関節炎、乏血壊死等の非炎症性関節炎（変形性関節疾患）、関節リウマチ等の炎症性関節炎、大腿骨頚部骨折等