美国食品药品管理局批准了个性化肩部手术工具, Catalyst OrthoScience gains FDA approval for personalized shoulder surgery tools, now available nationwide.

Catalyst OrthoScience已获得FDA 510（k）批准其用于肩关节置换的Archer®患者专用器械，使肱骨和肾盂关节骨的定制手术导向成为可能。 Catalyst OrthoScience has received FDA 510(k) clearance for its Archer® Patient-Specific Instrumentation for shoulder arthroplasty, enabling customized surgical guides for both humeral and glenoid bones. 该系统与3D-Side开发,支持解剖和反肩程序,与3D规划软件整合,目的是提高精确度、减少外科手术步骤并保存组织。 Developed with 3D-Side, the system supports anatomic and reverse shoulder procedures, integrates with 3D planning software, and aims to improve precision, reduce surgical steps, and preserve tissue. 已经开始对选定的外科医生进行有限的市场放行,在更广泛启动之前,有反馈指导最后的改进。 A limited market release with select surgeons has begun, with feedback guiding final refinements ahead of a wider launch. 现在全美都有这种技术可用。 The technology is now available across the U.S.