骨科产品开发商Trax Surgical镍钛合金缝合钉系统获得FDA 510(k)批准-动脉网

Trax Surgical Receives FDA 510(k) Clearance for Nitinol Staple System

CISION 等信源发布 2025-05-19 14:00

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STOUGHTON, Mass.

马萨诸塞州斯托顿

，

May 19, 2025

2025年5月19日

/PRNewswire/ -- Massachusetts based Trax Surgical, LLC, an orthopedic product development and distribution company principally serving the needs of the orthopedic extremities market, announced today that they received FDA 510(k) clearance to market the LINKT™ Compression Staple System. The staple system offers a range of nitinol staples for fracture repair, joint fusion, and osteotomy procedures..

/PRNewswire/ -- 总部位于马萨诸塞州的Trax Surgical有限公司是一家主要服务于骨科四肢市场的产品开发和分销公司，该公司今日宣布已获得FDA 510(k)许可，可上市销售LINKT™压缩钉系统。该钉系统提供一系列用于骨折修复、关节融合和截骨手术的镍钛诺钉。

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The LINKT™ System is comprised of a nitinol implant and deployment tools.

LINKT™ 系统由一个镍钛诺植入物和部署工具组成。

Compression bone staples have a key intraoperative advantage in that they are technically easier and faster to apply as fewer steps are required. This is an important option for surgeons to have when assessing the needs of their patients. Trax Surgical's nitinol staple with inherent compressive properties creates a stable environment that promotes bone healing.

压缩骨钉在术中有一个关键优势，即技术上更容易且更快应用，因为所需步骤更少。这是外科医生在评估患者需求时需要掌握的一个重要选择。Trax Surgical的镍钛诺骨钉具有固有的压缩特性，可创造一个促进骨骼愈合的稳定环境。

'We are incredibly excited about this advancement,' said .

“我们对这一进展感到无比兴奋，”他说。

Shane Shankle

肖恩·尚克勒

, President of Trax Surgical. 'The approval of our Nitinol Compression Staple enables us to better serve our customers and elevate the standard of care in extremity orthopedics. It reflects our dedication to innovation, quality, and the needs of both surgeons and patients.'

Trax Surgical总裁表示：“我们的镍钛诺压缩钉获得批准，使我们能够更好地服务客户，并提升四肢骨科护理的标准。这体现了我们对创新、质量以及外科医生和患者需求的承诺。”

The LINKT Compression Staple System is an improvement over some outdated designs that lack the ability to adjust the staple prior to implantation. The LINKT System features an adjustable inserter that allows the surgeon to open and close the staple's legs for easy insertion. Multiple staples can be deployed with an appropriately sized inserter, which is also used to properly seat the implant, or to remove and reposition it..

LINKT压缩钉系统改进了一些过时的设计，这些设计缺乏在植入前调整钉子的能力。LINKT系统具有一个可调节的插入器，允许外科医生打开和关闭钉子的腿以便于插入。多个钉子可以使用适当大小的插入器进行部署，该插入器还用于正确安置植入物，或将其移除并重新定位。

The company's nitinol staples have a slightly curved bridge designed to provide more even compression across the fusion site and feature toothed legs for secure fixation. LINKT Staples are available in multiple bridge widths and leg lengths. The LINKT system is comprised of staples sold individually in sterile packaging, and sterile deployment kits comprised of a drill, drill guide, locating pins, and inserter..

公司的镍钛诺钉书钉具有略微弯曲的桥架设计，旨在为融合部位提供更均匀的压缩，并配有带齿的腿以确保牢固固定。LINKT钉书钉有多种桥架宽度和腿长可供选择。LINKT系统由单独销售的无菌包装钉书钉组成，无菌部署套件包括钻头、钻头导向器、定位销和插入器。

About Trax Surgical

关于Trax Surgical

Trax Surgical manufactures innovative medical instrumentation and implant devices for surgical procedures involving the upper and lower extremities. They engineer premium medical products with patient comfort and durability in mind for internal fixation, reconstruction, and more. Bone and fracture repair products from Trax Surgical are quality-assured and certified to industry standards. The Trax Compression Screw System was initially developed by Primo Medical Group.

Trax Surgical公司生产用于上下肢手术的创新医疗仪器和植入装置。他们以患者舒适度和耐用性为考量，设计高品质的医疗产品，用于内固定、重建等手术。Trax Surgical的骨骼和骨折修复产品经过质量保证，并通过了行业标准认证。Trax Compression Screw System（Trax压缩螺钉系统）最初由Primo Medical Group开发。

Trax Surgical partners with Primo Medical Group to deliver innovative new products and medical devices certified to industry standards for surgical procedures..

Trax Surgical与Primo Medical Group合作，推出符合行业标准的创新新产品和医疗设备，用于外科手术。

About Primo Medical Group

关于普里莫医疗集团

Primo Medical Group offers the most comprehensive outsourcing solutions for the medical device market, including OEM product distribution services, engineering services, precision component production, finished goods assembly, medical device refurbishment, reusable surgical kit management and complete supply chain management.

普里莫医疗集团为医疗器械市场提供最全面的外包解决方案，包括OEM产品分销服务、工程服务、精密组件生产、成品组装、医疗器械翻新、可重复使用手术套件管理以及完整的供应链管理。

Established in 1953, Primo Medical Group is a privately held company with five facilities in Massachusetts. Primo Medical Group is an FDA Registered Contract Manufacturer and is compliant with FDA Quality Systems Regulations. Primo Medical Group is also ISO 13485:2016 certified and is a registered manufacturer with the Office of Defense Trade Controls Compliance.

Primo Medical Group 成立于1953年，是一家私营公司，在马萨诸塞州拥有五个设施。Primo Medical Group 是一家在FDA注册的合同制造商，并符合FDA质量体系法规。Primo Medical Group 还通过了ISO 13485:2016认证，并在美国国防贸易控制合规办公室注册为制造商。

Over the past 24 years Primo Medical Group has incubated and co-funded several new technologies including Angiolink, (acquired by Medtronic), Arthrosurface, Spirus Medical, (acquired by Olympus), Cardiosolutions, Saphena Medical (Acquired in 2024), Versago Vascular Access, Trax Surgical, and Solid State Marine..

在过去的24年中，普里莫医疗集团孵化并共同资助了多项新技术，包括Angiolink（被美敦力收购）、Arthrosurface、Spirus Medical（被奥林巴斯收购）、Cardiosolutions、Saphena Medical（2024年被收购）、Versago Vascular Access、Trax Surgical和Solid State Marine。

Contact:

联系：

Andrea Patisteas

安德烈亚·帕蒂斯亚斯

Senior Executive Vice President

高级执行副总裁

Trax Surgical

特拉克斯外科手术

SOURCE Trax Surgical

来源：Trax Surgical

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