Hip system - NMPA Registration 国械注准20243131922
Access comprehensive regulatory information for Hip system in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20243131922 and owned by Tianjin Zhengtian Medical Instrument Co., Ltd.. The device was approved on September 24, 2024.
This page provides complete registration details including registrant information, province location (Tianjin), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.
It is matched with the same system product of the company and is used as a cementless hip prosthesis, which is suitable for hip replacement.
与该企业同一系统产品匹配，作为非骨水泥型髋关节假体使用，适用于髋关节置换。
The hip system consists of a femoral stem, a ceramic ball joint, an acetabular outer cup and closure nail, an acetabular lining, an acetabular screw, and a defect block. The matrix material of the femoral stem and plugging nail is forged Ti6Al4V titanium alloy in accordance with YY 0117.1 standard, and the surface coating of the femoral stem and plugging nail is made of pure titanium powder in accordance with ASTM F1580; The ceramic ball head is made of zirconia toughened high-purity alumina-based composite ceramic in accordance with ISO 6474-2 standard; The acetabular outer cup and defect block are made of Ti6Al4V ELI powder that conforms to ASTM F3001 through electron beam melting rapid prototyping technology, and the solid structure and the three-dimensional porous structure on the outer surface are integrally molded. The acetabular lining is made of high-cross-linked ultra-high molecular weight polyethylene blended with vitamin E in accordance with ASTM F2695 and YY/T 0811; The acetabular screws are made of forged Ti6Al4V alloy in accordance with YY 0117.1. The products are delivered in a sterile state, the acetabular outer cup, occlusion nails, ceramic ball joint, femoral stem, defect block, acetabular screw are irradiated sterilized, and the acetabular lining is sterilized by ethylene oxide, and the sterilization validity period is 5 years.
髋关节系统由股骨柄、陶瓷球头、髋臼外杯及封堵钉、髋臼内衬、髋臼螺钉和缺损块组成。股骨柄、封堵钉的基体材料为符合YY 0117.1标准的锻造Ti6Al4V钛合金，股骨柄、封堵钉表面涂层由符合ASTM F1580的纯钛粉料制成；陶瓷球头由符合ISO 6474-2标准的氧化锆增韧高纯氧化铝基复合陶瓷制成；髋臼外杯、缺损块由符合ASTM F3001规定的Ti6Al4V ELI粉末经电子束熔融快速成型技术制成，实体结构与外表面三维多孔结构一体化成型；髋臼内衬由符合ASTM F2695和YY/T 0811的掺混维生素E的高交联超高分子量聚乙烯制成；髋臼螺钉由符合YY 0117.1的锻造Ti6Al4V合金制成。产品均以无菌状态交付，髋臼外杯、封堵钉、陶瓷球头、股骨柄、缺损块、髋臼螺钉为辐照灭菌，髋臼内衬为环氧乙烷灭菌，灭菌有效期为5年。