Approved by NMPA, 3D printed acetabulum product officially approved for market launch On September 25, 2025, the acetabulum component of the 3D printed hip joint prosthesis independently developed by Beijing Huakang Tianyi Biotechnology Co., Ltd. officially received approval from the National Medical Products Administration (NMPA) for market launch. The registration certificate number is GXZZ 20253131932, valid until September 24, 2030. The product consists of an acetabulum shell and an acetabul
Approved by NMPA: 3D-Printed Acetabular Product Officially Approved for Market Launch
On September 25, 2025, the 3D-printed hip prosthesis independently developed by Beijing Huakang Tianyi Biotech Co., Ltd. — the acetabular component — was officially approved for market launch by the National Medical Products Administration (NMPA). The registration certificate number is National Medical Device Registration Certificate No. 20253131932, valid until September 24, 2030. The product consists of an acetabular shell and acetabular augments. It is made of Ti6Al4VELI titanium alloy powder material conforming to the YY/T 1701 standard, manufactured by laser melting rapid prototyping technology, sterilized by gamma-ray irradiation, and has a validity period of 5 years.
The approval of this registration certificate marks a milestone breakthrough for Huakang Tianyi in the field of 3D-printed orthopedic implants, making the company one of the few domestic enterprises with large-scale production capacity for 3D-printed hip prostheses.
Facing Clinical Pain Points: The Severe Challenge of Bone Defects in Hip Revision
With the widespread adoption of artificial hip replacement, the demand for hip revision surgery is rising year by year. Scholars predict that by 2026, the total volume of hip revision surgeries in the United States will double from the current level, and this trend also applies to the Chinese market. In hip revision surgery, the management of acetabular bone defects is particularly difficult. Among them, Paprosky Type III acetabular defects, as the most severe type of bone defect, often result in the prosthesis being unable to obtain effective support.
Traditional solutions such as metal augmentation blocks, jumbo cups, or structural bone grafting are either difficult to match complex defect morphology or carry a high risk of complications. Studies show that the complication rate of using traditional methods to treat severe bone defects is as high as 30%. Facing this severe challenge, 3D-printed acetabular cups and augment technology, with their personalized design capabilities and biomimetic porous structures, are reshaping the treatment landscape of complex hip revision surgery.
Core Technical Advantages: From "Cutting the Foot to Fit the Shoe" to "Customizing According to the Bone"
The core advantages of Huakang Tianyi's 3D-printed acetabular products are reflected in three aspects:
First, precise anatomical reconstruction. Through 3D modeling based on patient CT data, 3D-printed augments can perfectly fit irregular bone defect morphology, achieving "customization according to the bone." A recent extreme case successfully treated by the team of Chief Physician Kang Pengde from the Department of Orthopedics at West China Hospital — a patient who developed severe osteolysis 25 years after total hip replacement, with the pelvis almost "hollowed out" — was successfully reconstructed with stability through a custom 3D-printed special acetabular prosthesis. Chengdu Third People's Hospital also used 3D printing technology to restore the three-dimensional shape of the acetabulum 1:1 for an elderly patient with old acetabular fracture combined with severe osteoarthritis, customizing a titanium alloy acetabular cup prosthesis and successfully repairing a large bone defect.
Second, biomimetic trabecular porous structure promotes bone ingrowth. The biomimetic trabecular porous structure adopted by Huakang Tianyi's 3D-printed acetabular products creates a three-dimensionally connected pore network with a porosity of up to 70%-80%, effectively simulating the human cancellous bone environment and providing ideal conditions for bone cell ingrowth. This structural design facilitates the ingrowth and integration of host bone and can achieve long-term stable fixation between the prosthesis and bone.
Third, high-precision implantation. A study on the implantation accuracy of custom acetabular components with iliac stem fixation showed that by comparing preoperative CT planning with postoperative X-ray results, this technology can achieve high-precision implantation — the average deviation of anteversion angle is only -0.25°, the abduction angle deviation is 1.7°, and the center of rotation deviation is minimal. Clinical practice at Chengdu Third People's Hospital shows that with the help of 3D printing technology, even the most complex hip replacement surgery can be completed within 90 minutes, with intraoperative blood loss of less than 200 milliliters.
R&D and Manufacturing Strength Supports Product Innovation
The successful approval of Huakang Tianyi's 3D-printed acetabular product is inseparable from the company's deep manufacturing foundation and continuous R&D investment. The company possesses advanced digital production equipment such as laser metal 3D printers, combined with precision testing equipment such as fully automatic three-coordinate measuring instruments, full-automatic projectors, and mechanical testing machines, achieving full-process digital quality control from raw materials to finished products.
The company has also established a biomechanics laboratory and a large-scale 3D orthopedic database, providing data support for product innovation. The company's expert advisory team mainly comes from many well-known domestic medical institutions such as Peking Union Medical College Hospital, Peking University People's Hospital, Beijing Jishuitan Hospital, and China-Japan Friendship Hospital. Relying on a strong expert team, the company has established the Beijing Huakang Orthopedic Academic Alliance and Technology Research Center, continuously committed to the research and application of new orthopedic technologies and new materials.
