Exactech, a global medical technology leader, announced the Equinoxe® Scapula Reconstruction System for acromial and scapular spine fractures has received 510(k) clearance

Exactech，一家全球医疗技术领导者，宣布Equinoxe®肩胛骨重建系统用于肩峰和肩胛骨脊柱骨折已获得510(k)许可。

from the U.S. Food and Drug Administration, marking a significant advancement in the treatment of acromial and scapular spine fractures.

来自美国食品药品监督管理局，标志着在治疗肩峰和肩胛骨脊柱骨折方面取得了重要进展。

First-to-Market Scapula Reconstruction System for Acromial Stress Fractures Receives FDA Clearance

首个用于肩胛骨应力性骨折的肩峰重建系统获得FDA批准上市

Acromial and scapular fractures are a rare but devastating complication that can occur among every rTSA implant design. The reported rate of acromial and scapular fractures after rTSA averages 2.8 percent but can be as high as 10.9 percent for some patient diagnoses.

肩峰和肩胛骨骨折是每种反向全肩关节置换术（rTSA）植入设计中都可能出现的罕见但严重的并发症。报道显示，rTSA术后肩峰和肩胛骨骨折的平均发生率为2.8％，但对于某些患者诊断，这一比率可能高达10.9％。

There is currently no accepted treatment solution for patients with this challenging rTSA complication. Recognizing this unmet clinical need, Exactech developed a novel solution to help surgeons treat this unique complication.

目前，对于这种棘手的反向全肩关节置换术（rTSA）并发症患者，尚无公认的治疗方案。意识到这一未满足的临床需求后，Exactech 开发了一种新颖的解决方案，以帮助外科医生治疗这一独特的并发症。

Designed by

设计者

Jonathan Levy

乔纳森·利维

, MD,

，医学博士，

Howard Routman

霍华德·鲁特曼

Peter Cole

彼得·科尔

, MD,

，医学博士，

George Athwal

乔治·阿特瓦尔

, MD,

，医学博士，

Michael McKee

迈克尔·麦基

, MD, and

，医学博士，和

Joaquin Sanchez-Sotelo

华金·桑切斯-索特洛

, MD, PhD, the Equinoxe Scapula Reconstruction System is the only trauma solution designed to treat acromial and scapular fractures with rTSA in mind.

，医学博士，Equinoxe肩胛骨重建系统是唯一考虑到反向全肩关节置换术（rTSA）的创伤解决方案，用于治疗肩峰和肩胛骨骨折。

'We organized a world-class design team to develop this comprehensive scapular plating system, bringing together surgeons with deep and diverse experience with rTSA implant designs from nearly every major manufacturer,' said

“我们组织了一支世界级的设计团队，来开发这一综合性的肩胛骨板系统，汇聚了具有丰富和多样经验的外科医生，他们熟悉来自几乎所有主要制造商的反向全肩关节置换术（rTSA）植入物设计，”

Chris Roche

克里斯·罗切

, Exactech's Sr. Vice President, Extremities. 'This team collaborated to develop what we believe is the definitive treatment solution for acromial and scapular rTSA fracture patterns, an achievement that shows what's possible when surgeons and industry work together to solve challenges. I am proud that Exactech is the first to provide a system with design elements that help support surgeons in managing these complex cases.' .

，Exactech的高级副总裁，四肢部门。‘这个团队合作开发了我们认为是针对肩峰和肩胛骨rTSA骨折模式的最终治疗解决方案，这一成就展示了当外科医生和行业共同努力解决挑战时所能实现的可能性。我为Exactech能率先提供一个拥有设计元素、可帮助外科医生处理这些复杂病例的系统而感到自豪。’

The Equinoxe Scapula Reconstruction System allows orthopedic surgeons to treat scapular fractures using several different techniques, including single and dual plating, regardless of placement of any particular rTSA implant design. This novel system features a versatile portfolio of anatomically contoured plates provided in multiple lengths to enable precise fracture management across the range of patient anatomy with the goal of restoring function..

Equinoxe肩胛骨重建系统允许骨科医生使用多种不同的技术来治疗肩胛骨骨折，包括单板和双板固定，无论任何特定反向全肩关节置换术（rTSA）植入物设计的放置位置如何。这一新型系统提供了一系列多功能的解剖型轮廓钢板，具有多种长度选择，旨在针对不同患者解剖结构实现精确的骨折管理，以恢复功能。

'Finally, a plating system specifically designed for management of this challenging complication will be available in

‘最后，一个专门为管理这一棘手并发症而设计的电镀系统将会面世。

the United States

美国

Howard Routman

霍华德·劳特曼

, DO (Atlantis Orthopedics). 'This dual plating system is impactful because it was designed to not only respect the variable scapular anatomy and variable fracture patterns, but also because it respects the unique biomechanics of the rTSA, which stresses the scapular bone uniquely. The release of this implant will represent a new paradigm for open reduction internal fixation of acromial and scapular spine fractures.'.

，DO（亚特兰大骨科）。"这种双板系统之所以有影响力，是因为它不仅考虑到肩胛骨解剖结构和骨折模式的多变性，还因为它尊重了反向全肩关节置换术（rTSA）的独特生物力学，这种手术对肩胛骨骨骼施加了独特的压力。这款植入物的发布将代表肩峰和肩胛骨脊柱骨折开放复位内固定的新范式。"

The Equinoxe Scapula Reconstruction System includes a range of different plate designs incorporating many differentiated features to tailor treatment across the Levy

Equinoxe肩胛骨重建系统包括一系列不同的钢板设计，包含多种差异化特性，以针对Levy分类进行个性化治疗。

Type I, II, IIA and IIB fracture classification patterns. Most significantly, each contoured plate includes one or more integral hooks (located anteriorly on the acromion, laterally on the acromion and/or a hook along the medial scapular border) to support the scapula and counteract the pull of the deltoid and the biomechanical loading of the rTSA prosthesis.

I型、II型、IIA型和IIB型骨折分类模式。最重要的是，每个轮廓板包括一个或多个整体钩（位于肩峰前部、肩峰外侧和/或沿肩胛骨内侧边缘的钩），以支撑肩胛骨并抵消三角肌的拉力和反向肩关节置换术假体的生物力学负荷。

Previous laboratory research has suggested that the use of a lateral hook plate improved fixation of the lateral acromion..

以往的实验室研究表明，使用侧向钩板可以改善侧向肩峰的固定。

'I've spent the better part of my career trying to figure out how and why acromial fractures occur after reverse shoulder replacement,' said

“我职业生涯的大部分时间都在试图弄清楚为什么在反向肩关节置换术后会发生肩峰骨折，”他说。

Jonathan Levy

乔纳森·利维

, MD, Paley Orthopedic and Spine Institute. 'I am proud of the plating system that we have developed – an implant system for acute treatment which will help bring much-needed attention to manage this often-devastating complication.'

，医学博士，波利骨科和脊柱研究所。 “我们开发的钢板系统让我感到自豪——这是一种用于急性治疗的植入系统，将有助于引起人们对管理这一常常令人痛苦的并发症的必要关注。”

Current American Shoulder and Elbow Surgeons President

当前美国肩肘外科医生协会主席

Joaquin Sanchez-Sotelo

华金·桑切斯-索特洛

, Mayo Clinic, added, 'This anatomically contoured dual plating system is designed specifically for treatment of fractures associated with reverse shoulder arthroplasty. It incorporates hooks to brace and support the acromion and is truly a game changer.'

梅奥诊所补充道：“这种解剖学轮廓的双板系统专为反向肩关节置换术相关的骨折治疗而设计。它包含用于支撑和支撑肩峰的钩子，确实是一项改变游戏规则的技术。”

The Equinoxe Scapula Reconstruction System will enter pilot launch with limited availability in the U.S. later this year. For more information, visit

Equinoxe肩胛骨重建系统将于今年晚些时候在美国进行有限供应的试点发布。欲了解更多信息，请访问

About Exactech

关于Exactech

Exactech is a global medical technology leader that empowers orthopaedic surgeons with innovative implants, surgical instruments and the Active Intelligence® (AI) ecosystem of smart technologies to give patients EXACTLY what they need to regain mobility. Visit

精确科技是一家全球医疗技术领导者，通过创新的植入物、手术器械和Active Intelligence®（AI）智能技术生态系统，为骨科医生提供支持，从而为患者提供确切所需，帮助他们恢复行动能力。敬请访问