Palm Beach Gardens, FL – June 7, 2024 – Today, Johnson & Johnson MedTech announced that DePuy Synthes, The Orthopaedics Company of Johnson & Johnson*, has received 510(k) FDA clearance for the clinical application of the VELYS™ Robotic-Assisted Solution in Unicompartmental Knee Arthroplasty (UKA).

强生医疗技术宣布，其正骨公司的 DePuy Synthes已获得 510(k) FDA 对 VELYS™ 机器人辅助解决方案在单间室膝关节置换术（UKA）中的临床应用的批准。

The expanded indication builds upon the VELYS Robotic-Assisted Solution platform used in Total Knee Arthroplasty (TKA), which has been cleared for use in 20 markets and utilized in over 55,000 procedures, equipping surgeons with the information needed to help preserve the soft tissue envelope, predict joint stability and work toward returning knee function.

这一扩展适应症建立在用于全膝关节置换术（TKA）的 VELYS 机器人辅助解决方案平台上，该平台已在20个市场获得使用许可，并在超过55,000例手术中使用，为外科医生提供了帮助保护软组织包膜、预测关节稳定性和努力恢复膝关节功能所需的信息。

The UKA application is designed for both medial and lateral procedures and will enable surgeons to guide precise implant placement without a CT scan.

单间室膝关节置换术（UKA）应用设计用于内侧和外侧手术，并将使外科医生能够在没有 CT 扫描的情况下指导精确植入物放置。

It is compatible with the SIGMA™ HP Unicondylar Knee System with the new reusable INTUITION™ INSTRUMENTS.

它与带有新型可重复使用的 INTUITION™ 工具的 SIGMA™ HP 单髁膝关节系统兼容。

The SIGMA™ HP Implant demonstrates improved 12-year survivorship compared to class5 as shown in a national joint registry.

SIGMA™ HP 植入物在国家联合注册处显示与同类产品相比提高了12年存活率。

“We are committed to continually improving and expanding the capabilities and user experience of our VELYS™ Enabling Technology portfolio,” said Aldo Denti, Company Group Chairman, DePuy Synthes. “Data and analytics will continue to serve as the backbone of our platform, which reveals real-time, actionable insights for surgeons to empower patient-specific operative decisions with the goal to improve outcomes and deliver personalization at scale.”

“我们致力于不断改进和扩展我们的 VELYS™ 使能技术产品组合的能力和用户体验，”DePuy Synthes 集团公司董事长 Aldo Denti 说。“数据和分析将继续作为我们平台的支柱，揭示外科医生的实时、可操作的洞察，以实现改善结果和大规模提供个性化的目标。”

Unicompartmental knee arthroplasty, otherwise known as partial knee replacement, offers potential for bone preservation6 and shortened recovery periods.

单间室膝关节置换术，也称为部分膝关节置换术，提供了骨保存和缩短恢复期的潜力。

UKA utilization offers clinical benefits and greater economic efficiency for patients, providers and payors compared to TKA7-8.

与全膝关节置换术（TKA）相比，UKA 的使用为患者、提供者和支付者提供了临床益处和更大的经济效率7-8。

Robotics has the opportunity to overcome many of the challenges surgeons face in manual partial knee replacement when they are designed to provide intra-operative insights, more accurate implant alignment and positioning, and more reproducible and consistent outcomes.

机器人技术有机会克服外科医生在手工部分膝关节置换中面临的许多挑战，当它们被设计为提供术中洞察、更准确的植入物对齐和定位以及更可复制和一致的结果时。

“Challenges associated with partial knee replacement include lack of access and visibility, which can lead to a longer learning curve and variability in outcomes. Achieving precise alignment and optimal implant placement is paramount for long-term success, and the ability to do so in a reproducible manner continues to be an unmet need in the UKA space,”said Dr. John Redmond, orthopedic surgeon performing both knee and hip procedures in Jacksonville, FL.

“与部分膝关节置换相关的挑战包括缺乏通路和可见性，这可能导致更长的学习曲线和结果的变异性。实现精确对齐和最佳植入物放置对于长期成功至关重要，以可复制的方式做到这一点在 UKA 领域仍然是一个未满足的需求。”在佛罗里达州杰克逊维尔进行膝关节和髋关节手术的整形外科医生 John Redmond 博士所说。

“VELYS™ Robotic-Assisted Solution for Unicompartmental Knee Arthroplasty will enable a more personalized procedure that helps drive reproducible outcomes, while insights delivered from its planning and balancing tools will enable better precision and accuracy. I am excited to see it utilized for UKA procedures and particularly in the ambulatory surgery center setting where its smaller footprint and image-free technology will enable greater operational efficiency.”

“VELYS™ 机器人辅助单间室膝关节置换解决方案将实现更个性化的程序，有助于推动可复制的结果，同时其规划和平衡工具提供的洞察将实现更好的精确度和准确性。我很高兴看到它被用于 UKA 程序，特别是在门诊手术中心环境中，它更小的占地面积和无图像技术将实现更大的运营效率。”

Key features of the VELYS™ Robotic-Assisted Solution for UKA include: - The single PROADJUST™ PLANNING SCREEN enables personalized planning to help ensure precise implant placement, alignment, and balance relative to soft tissue. - An ACCUBALANCETM GRAPH for personalized balancing throughout the full range of motion. - Compatibility with the SIGMATM HP Unicondylar Knee System that has been demonstrated to improve 12-year survivorship compared with its class. - Complete UKA workflow with UKA-specific functionality.

VELYS™ 机器人辅助 UKA 解决方案的关键特点包括： - 单一 PROADJUST™ 规划屏幕可实现个性化规划，帮助确保相对于软组织的精确植入物放置、对齐和平衡。 - ACCUBALANCETM 图表用于全运动范围内的个性化平衡。 - 与 SIGMATM HP 单髁膝关节系统兼容，已被证明与同类产品相比提高了12年存活率。 - 具有 UKA 特定功能的完整 UKA 工作流程。

The system will be featured at the Annual Meeting of the American Association of Hip and Knee Surgeons in November.

该系统将在11月的美国髋膝关节外科医师年会上展出。