Metallic femoral head
Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Theo theo phụ lục·Registered Apr 18, 2023- Analysis ID
- 2300295ĐKLH/BYT-TB-CT
- Submission ID
- 17001883/ĐKLH-BYT-TB-CT
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Theo theo phụ lục
- Manufacturer Country
- Theo theo phụ lục
- Intended Use
- The metal-on-metal ARTICUL/EZE femoral head is a component of the total hip arthroplasty system, designed to replace the natural joint surface of the hip. THE TOTAL HIP ARTHROPLASTY SYSTEM Total hip arthroplasty surgery is indicated to improve the mobility of the patient and reduce pain by replacing the damaged hip joint surface in patients who have been proven to have sufficient healthy bone to anchor and support the artificial joint components. INDICATIONS - THE TOTAL HIP ARTHROPLASTY SYSTEM Total hip arthroplasty surgery is indicated in the following conditions: 1. Severe pain and/or hip joint disability due to chronic arthritis, arthritis after trauma, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute fracture of the femoral head or neck due to trauma. 4. Failure of previous hip surgery, including arthroplasty, intramedullary fixation, arthrodesis, hemiarthroplasty, surface resurfacing, or total hip arthroplasty. 5. Certain cases of joint stiffness. Total hip arthroplasty surgery may be considered in younger patients, if, in the opinion of the surgeon, the clear indication for total hip arthroplasty outweighs the risks associated with the patient's age and if the requirements for range of motion and load-bearing of the hip joint can be met (see the section WARNING AND PRECAUTIONS). This section includes severely disabled patients with multiple joint involvement, for whom the improvement in hip joint mobility may result in a significant improvement in quality of life. Modular femoral heads and stem components A modular metal femoral head or DePuy metal femoral head is used with the DePuy stem component. The socket is replaced with a two-piece UHMWPE socket component lined with metal, ceramic, or metal, or entirely with UHMWPE, and uses a UHMWPE load-bearing surface, or ceramic* with an internal diameter equal to the external diameter of the modular femoral head used.
- Registration Date
- Apr 18, 2023
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Access comprehensive regulatory information for Metallic femoral head in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2300295ĐKLH/BYT-TB-CT and manufactured by Theo theo phụ lục.
This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including DePuy (Ireland), and 1 recent registrations in the same category. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.