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京瓷深耕骨科高端陶瓷材料研发领域已有五十余年，始终引领行业发展，长期为髋关节与膝关节植入物市场赋能。
Kyocera has been a leader in the development of advanced ceramic materials for orthopedic applications, with over five decades of contributions to the hip and knee implant markets.
公司推出BIOCERAM AZUL®等氧化锆增韧氧化铝材料（ZTA），实现陶瓷技术重大突破。BIOCERAM AZUL®兼具氧化铝优异的力学性能与氧化锆高强韧性，具备更出色的相稳定性、耐磨性与长效耐用性，是骨科承重植入物的理想用材。依托前沿材料制备及加工技术，该材料可精准调控微观晶粒尺寸，即便在极限受力环境下，也能拥有优异的断裂韧性、减少磨损碎屑，整体力学性能大幅提升。
京瓷经过多年上市后临床随访研究，对四千余名接受全髋关节置换术与双极髋关节置换术的患者进行为期两年（6 个月、12 个月、24 个月）跟踪观察。随访结果显示，采用BIOCERAM AZUL®的置换系统，两年整体翻修率低于 1%。目前该款球头临床植入量已超 13 万例，暂无陶瓷断裂病例上报，临床使用安全性可靠。上述研究充分证实，该材料可保障全髋关节置换手术安全长效的治疗效果，BIOCERAM AZUL®也成为骨科临床应用的可靠选材。
The company’s innovations, including the introduction of zirconiatoughened alumina (ZTA) materials such as BIOCERAM AZUL®, represent significant advancements in ceramic technology. BIOCERAM AZUL® integrates the exceptional mechanical properties of alumina (Al₂O₃) with the toughness of zirconia (ZrO₂). It exhibits enhanced phase stability, wear resistance, and longterm durability, which are crucial for load-bearing applications in orthopedic implants. Utilizing the latest technological advancements in material processing, BIOCERAM AZUL® maintains a finely controlled microstructure with reduced grain size. This results in superior fracture toughness, reduced wear debris, and enhanced mechanical performance, even under extreme loading conditions.
Kyocera conducted a multicenter post-market clinical follow-up study (PMCF), surveilling more than 4,000 patients with total hip (THA) or bipolar hip arthroplasty (BHA) with 2 years (6, 12, 24 months) follow-up. The THA and BHA systems with BIOCERAM AZUL® ball heads showed <1% overall revision rates at 2-year follow-ups. Over 130,000 ball heads have been successfully implanted, with no reported ceramic fractures, demonstrating their clinical reliability. These findings underscore the material’s potential to deliver safe, long-lasting outcomes in total hip arthroplasty (THA), establishing BIOCERAM AZUL® as a reliable choice for orthopedic applications.
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