WARSAW, Ind., Feb. 22, 2024 /PRNewswire/ -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology leader, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the ROSA® Shoulder System for robotic-assisted shoulder replacement surgery. ROSA Shoulder is the world's first robotic surgery system for shoulder replacement, and the fourth application for the Company's comprehensive ROSA® Robotics portfolio, which includes the ROSA® Knee System for total knee arthroplasty and ROSA® Hip System for total hip replacement..

华沙，印第安纳州。，2024年2月22日，全球医疗技术领导者齐默生物科技控股有限公司（纽约证交所和第六证交所：ZBH）今天宣布。S、 美国食品和药物管理局（FDA）510（k）批准ROSA®肩部系统用于机器人辅助肩关节置换手术。ROSA肩部是世界上第一个用于肩关节置换的机器人手术系统，也是该公司全面的ROSA®机器人产品组合的第四个应用，其中包括用于全膝关节置换术的ROSA®膝关节系统和用于全髋关节置换术的ROSA®髋关节系统。。

ROSA Shoulder strengthens Zimmer Biomet's innovative shoulder implant portfolio, which includes the Identity Shoulder System, and joins ZBEdge™ Dynamic Intelligence™, which has the power to enhance the company's cutting-edge digital technologies, robotics and implant solutions.

ROSA Shoulder加强了Zimmer Biomet创新的肩部植入产品组合，其中包括Identity Shoulder系统，并加入了ZBEdge™Dynamic Intelligence™，该产品具有增强公司尖端数字技术、机器人技术和植入解决方案的能力。

'We are proud and excited to be the first company in the world to deliver a robotic surgical assistant for anatomic and reverse shoulder replacement surgery,' said Ivan Tornos, President and Chief Executive Officer at Zimmer Biomet. 'ROSA Shoulder represents a novel advancement intended to help surgeons leverage the power of robotics and data analytics to perform highly complex shoulder procedures with accuracy1 and efficiency.'.

齐默生物科技公司总裁兼首席执行官伊万·托诺斯（IvanTornos）说，我们为成为世界上第一家为解剖和逆向肩关节置换手术提供机器人手术助手的公司而感到骄傲和兴奋ROSA肩部代表了一项新的进步，旨在帮助外科医生利用机器人和数据分析的力量，准确高效地执行高度复杂的肩部手术。”。

ROSA Shoulder is designed to give surgeons the flexibility to execute a total shoulder replacement using anatomic or reverse techniques and to enable precise placement for improved outcomes1. ROSA Shoulder is one of the only systems that can reproduce humeral head resectioning, and can ease insertion of instruments into incisions by requiring no pin in the center of the glenoid during procedures.

ROSA肩关节旨在为外科医生提供灵活性，使用解剖或反向技术进行全肩关节置换，并能够精确放置以改善结果1。ROSA肩关节是唯一可以复制肱骨头切除术的系统之一，并且可以通过在手术过程中不需要在关节盂中心插入针来轻松将器械插入切口。

Like all ROSA Robotics applications, ROSA Shoulder is designed to support data-informed physician decision-making based on a patient's unique anatomy. Pre-operatively, ROSA Shoulder integrates with the newly released Signature™ ONE Surgical Planning System 2.0, which uses a 3-D image-based approach to visualization, surgical planning and patient-specific guide creation.

像所有ROSA机器人应用程序一样，ROSA肩部旨在支持基于患者独特解剖结构的数据知情医生决策。术前，ROSA肩部与新发布的Signature™ONE手术计划系统2.0集成，该系统使用基于3-D图像的方法进行可视化，手术计划和患者特定指南的创建。

During the surgery, the platform provides surgeons with real-time, intra-operative data to help them control, execute and validate personalized plans for glenoid and humeral placement1, with a goal to reduce complications for patients.2,3,4,5.

在手术过程中，该平台为外科医生提供实时的术中数据，以帮助他们控制，执行和验证关节盂和肱骨放置的个性化计划1，目的是减少患者的并发症[2,3,4,5]。

'One of the challenging aspects of performing a shoulder replacement is accurate glenoid and humeral placement, which is a critical factor for post-operative function and long-term implant survival,' said John W. Sperling, MD, MBA, Professor of Orthopedic Surgery at Mayo Clinic. 'This innovative approach is designed to allow surgeons to virtually walk through a procedure before making any resections, and then receive live feedback and the ability to control glenoid ream depth and intra-operatively validate cut resections during the procedure.'.

梅奥诊所（Mayo Clinic）矫形外科教授、MBA医学博士约翰·斯珀林（JohnW.Sperling）说：“肩关节置换术的挑战之一是准确的关节盂和肱骨放置，这是术后功能和植入物长期存活的关键因素。”这种创新的方法旨在使外科医生在进行任何切除之前能够真正完成手术，然后获得实时反馈以及控制关节盂扩张深度和术中验证手术切除的能力。”。

ROSA Shoulder will be commercially available in the U.S. in the second half of 2024, and will work with the mymobility® Digital Care Management Platform to bolster the ZBEdge Dynamic Intelligence portfolio for patients undergoing shoulder replacement surgery.

ROSA肩部将于2024年下半年在美国上市，并将与mymobility®数字护理管理平台合作，为接受肩关节置换手术的患者提供ZBEdge动态智能组合。

About Zimmer Biomet

关于Zimmer Biomet

Zimmer Biomet is a global medical technology leader with a comprehensive portfolio designed to maximize mobility and improve health. We seamlessly transform the patient experience through our innovative products and suite of integrated digital and robotic technologies that leverage data, data analytics and artificial intelligence..

Zimmer Biomet是全球医疗技术领导者，拥有全面的产品组合，旨在最大限度地提高流动性和改善健康。我们通过利用数据、数据分析和人工智能的创新产品和集成数字和机器人技术套件，无缝地改变患者体验。。

With 90+ years of trusted leadership and proven expertise, Zimmer Biomet is positioned to deliver the highest quality solutions to patients and providers. Our legacy continues to come to life today through our progressive culture of evolution and innovation.

Zimmer Biomet拥有90多年值得信赖的领导才能和成熟的专业知识，致力于为患者和提供者提供最高质量的解决方案。今天，通过我们进步的进化和创新文化，我们的遗产继续焕发活力。