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Zimmer Biomet Receives FDA Clearance for OsseoFit Stemless Shoulder System for Total Shoulder Replacement

Zimmer Biomet Receives FDA Clearance for OsseoFit Stemless Shoulder System for Total Shoulder Replacement

Zimmer Biomet獲得FDA批准,推出無干預式OsseoFit肩關節系統用於整體肩關節置換。
PR Newswire ·  12/13 07:30

New Anatomically Shaped Asymmetric Stemless Design for Total Shoulder Replacement

新的人體解剖形狀不對稱無杆設計,用於全肩關節置換

WARSAW, Ind., Dec. 13, 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 for the OsseoFit Stemless Shoulder System for total shoulder replacement. This innovative implant is designed to match the natural humeral (upper shoulder bone) anatomy1-3 to optimize anatomical fit while maximizing preservation of healthy bone. The OsseoFit Stemless Shoulder System expands the company's expansive total shoulder portfolio and integrates with Identity Humeral Heads with Versa-Dial Technology for infinite offset placement as well as the Alliance Glenoid for a broad range of glenoid options to adapt to a patient's unique anatomy.

美國印第安納州華沙,2024年12月13日 /PRNewswire/ -- 齊默巴奧米特控股公司(紐交所和瑞士證券交易所:ZBH),全球領先的醫療科技公司,今天宣佈獲得美國食品和藥物管理局(FDA)510(k)批准,用於全肩關節置換的OsseoFit無杆肩關節系統。這款創新的植入物旨在與自然的肱骨(上肩骨)解剖結構相匹配,以優化解剖適應性,同時最大限度地保留健康骨骼。OsseoFit無杆肩關節系統擴展了公司廣泛的全肩關節產品組合,並可與Identity肱骨頭和Versa-Dial科技集成,實現無限偏移放置,以及與Alliance盂配合,提供廣泛的盂部選項,以適應患者獨特的解剖結構。

"The OsseoFit Stemless Shoulder System combines an anatomically shaped implant1-3 which supports bone conservation and is designed for stable initial fixation4-7, with our proprietary OsseoTi Porous Metal Technology for biological fixation,"8,9* said Brian Hatcher, President, SET & CMFT at Zimmer Biomet. "We are pleased to offer OsseoFit within our robust shoulder portfolio that includes modular, compatible components which provide surgeons with a multitude of options based on patients' unique anatomy while maintaining a small instrument footprint and maximizing workflow efficiency."

齊默巴奧米特的總裁布賴恩·哈切爾(Brian Hatcher)表示:「OsseoFit無杆肩關節系統結合了具有解剖形狀的植入物,支持骨骼保護,並設計用於穩定的初始固定,與我們專有的OsseoTi多孔金屬科技結合,促進生物固定。」我們很高興能在我們強大的肩關節產品組合中提供OsseoFit,其中包括模塊化、兼容的元件,爲外科醫生提供基於患者獨特解剖結構的多種選擇,同時保持小型器械佔位,並最大化工作流程效率。

The anatomically designed left- or-right-sided anchor implants feature fins which create a press-fit during insertion and contain fully porous windows. The fin geometry and anchor spacing of the implant determine proper orientation and fit1-3 into the natural bone and help avoid cortical impingement, while reaching dense bone areas.2,3,10 In addition, the design includes strategically located anterior reattachment suture holes on the anchor to facilitate subscapularis repair. The system is available in a singular instrument tray to maximize workflow, and sterile process efficiency, to fit nicely in a variety of settings including ambulatory surgical centers.

這種解剖設計的左右側錨植入物具有在插入過程中產生壓緊配合的鰭,幷包含完全多孔的窗口。植入物的鰭幾何形狀和錨間距判斷正確的方向和適合程度,以適應自然骨骼並幫助避免皮質擠壓,同時到達稠密骨區。此外,設計中包括位於錨上的前部縫合孔,以促進肩胛下肌的修復。該系統提供在一個儀器托盤中,最大化工作流程和無菌過程效率,適合包括門診手術中心在內的多種環境。

"As younger and more active patients require shoulder replacements, bone preservation becomes increasingly critical to accommodate potential revision procedures in the future," said John W. Sperling, MD, MBA, Professor of Orthopedic Surgery at Mayo Clinic, and a member of the OsseoFit Stemless Shoulder System surgeon development team. "Using a method that mimics the asymmetry of the natural humerus enables surgeons to preserve native bone while optimizing fixation."

「隨着年輕和更活躍的患者需要肩關節置換,骨骼的保護變得愈加重要,以適應未來潛在的修復程序,」梅奧診所骨科手術教授、OsseoFit無杆肩關節系統外科醫生開發團隊成員約翰·W·斯佩林(John W. Sperling)醫學博士、工商管理碩士說。「採用一種模仿自然肱骨不對稱的方法,使外科醫生能夠在優化固定的同時保留原生骨。」

The OsseoFit Stemless Shoulder will be commercially available in Q1 2025.

OsseoFit無杆肩關節將在2025年第一季度商業推出。

Mayo Clinic has a financial interest in the technology referenced in this press release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.

梅奧診所在本新聞稿中提到的科技方面有經濟利益。梅奧診所將利用其所獲得的營業收入支持其非營利使命,包括患者護理、教育和研究。

About 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.

關於齊默巴奧米特控股
齊默巴奧米特控股是全球醫療科技領導者,擁有全面的產品組合,旨在最大化移動性並改善健康。我們通過創新產品和一整套集成的數字化及機器人科技在患者體驗上實現無縫轉變,這些科技利用數據、數據分析和人工智能。

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.

憑藉90多年值得信賴的領導地位和證明的專業知識,齊默巴奧米特控股在爲患者和提供者提供最高質量解決方案方面處於領先地位。我們的遺產通過不斷進步的文化和創新精神在今天繼續延續。

For more information about our product portfolio, our operations in 25+ countries and sales in 100+ countries or about joining our team, visit or follow on LinkedIn at or X / Twitter at .

有關我們產品組合的信息、我們在25多個國家的運營和在100多個國家的銷售,或關於加入我們團隊的詳細信息,請訪問或在LinkedIn上關注,或在X / Twitter上關注。

Cautionary Statement Regarding Forward-Looking Statements

關於前瞻性聲明的警示聲明

This news release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet's expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes. Such statements are based upon the current beliefs and expectations of management and are subject to significant risks, uncertainties and changes in circumstances that could cause actual outcomes and results to differ materially. For a list and description of some of such risks and uncertainties, see Zimmer Biomet's periodic reports filed with the U.S. Securities and Exchange Commission (SEC). These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet's filings with the SEC. Forward-looking statements speak only as of the date they are made, and Zimmer Biomet disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Readers of this news release are cautioned not to rely on these forward-looking statements, since there can be no assurance that these forward-looking statements will prove to be accurate. This cautionary statement is applicable to all forward-looking statements contained in this news release.

本新聞發佈包含1995年《私人證券訴訟改革法》的安全港條款所指的前瞻性陳述。前瞻性陳述包括但不限於有關齊默巴奧米特的期望、計劃、前景以及產品和服務提供的聲明,包括新產品發佈和潛在的臨床成功。這些陳述基於管理層當前的信念和期望,並受到重大風險、不確定性和情況變化的影響,這可能導致實際結果與預期有重大差異。有關某些此類風險和不確定性的列表及描述,請參見齊默巴奧米特向美國證券交易委員會(SEC)提交的定期報告。這些因素不應被解釋爲詳盡的,並應與齊默巴奧米特在SEC提交的其他警示性聲明一起閱讀。前瞻性陳述僅在作出之日有效,齊默巴奧米特免責聲明對任何前瞻性陳述進行更新或修訂的意圖或義務,無論是由於新信息、未來事件或其他原因。本新聞發佈的讀者被警告不要依賴這些前瞻性陳述,因爲不能保證這些前瞻性陳述將被證明是準確的。此警示聲明適用於本新聞發佈中包含的所有前瞻性陳述。

References

參考文獻

*Animal Studies are not necessarily indicative of clinical performance.

*動物研究不一定能反映臨床表現。

  1. Mueri, C., Snethen, K., Parisi, R., Son, Yang., Duquin, T. Characterization of the Asymmetric Bone Envelope of the Proximal Humeral Metaphysis for Stemless Shoulder Implants. Accepted for presentation at the ORS Orthopaedic Research Society 2025 Annual Meeting; 2025 Feb 7-11; Phoenix, Arizona.
  2. Son, Y, Mueri, C., Snethen, K., Bowman, L., Parisi, R., Duquin, T. Optimizing Stemless Humeral Anchors: Asymmetrical Designs for Minimizing Cortical Bone Impingement while Maximizing Cancellous Bone Purchase. Accepted for presentation at the ORS Orthopaedic Research Society 2025 Annual Meeting; 2025 Feb 7-11; Phoenix, Arizona.
  3. ZRR_WI_6743_24. Zimmer Biomet Internal Research Report on File.
  4. Snethen, K., Mueri, C., Kriska, T., Son, Y., Bandi, M. The Sensitivity of the Stability of Stemless Humeral Implants to Surgical, Patient and Design Factors in Reverse Shoulder Arthroplasty. Presented at the ORS Orthopaedic Research Society Annual Meeting; 2023, Dallas, Texas.
  5. Snethen, K., Son, Y., Mueri, C., Bischoff, J. The Effect of Press-fit on Initial Stability in Stemless Shoulder Arthroplasty. Presented at the ISTA International Society for Technology in Arthroplasty Annual Meeting; 2022, Maui, Hawaii.
  6. Snethen, K., Mueri, C., Son, Y., Parisi, R., Duquin, T. The Effect of Geometric Design on Initial Stability of Stemless. Accepted for presentation at the ORS Orthopaedic Research Society 2025 Annual Meeting; 2025 Feb 7-11; Phoenix, Arizona.
  7. ZBTR_30118. Zimmer Biomet Internal Research Report on File.
  8. OsseoTi Porous Metal Technology uses anatomical data in combination with 3D printing technology to build a structure designed to mimic the architecture of human cancellous – or spongey - bone.
  9. Gupta, G. Evaluation of Bony Ingrowth Implant Materials in an In Vivo Sheep Long Bone Defect Model 12-04/12-07, February 2013. 32.
  10. Hamidreza Alidousti, Joshua W Giles, Roger J H Emery, Jonathan Jeffers, Spatial mapping of humeral head bone density, Journal of Shoulder and Elbow Surgery 2017, Vol 26, 1653-1661.
  1. Mueri, C., Snethen萬., Parisi, R., Son, Yang., Duquin萬億。對無干擾肩關節植入物近端肱骨幹骺的非對稱骨包絡特徵進行研究。已接受在2025年ORS骨科研究學會年會上展示;2025年2月7-11日;亞利桑那州鳳凰城。
  2. Son, Y, Mueri, C., Snethen萬., Bowman, L., Parisi, R., Duquin萬億。優化無干擾肱骨錨:減少皮質骨幹擾並最大化松質骨購買的非對稱設計。已接受在2025年ORS骨科研究學會年會上展示;2025年2月7-11日;亞利桑那州鳳凰城。
  3. ZRR_WI_6743_24. 齊默巴奧米特內部研究報告存檔。
  4. Snethen萬., Mueri, C., Kriska萬億., Son, Y., Bandi萬. 在逆向肩關節置換術中,無干預肱骨植入物穩定性的敏感性與外科、患者及設計因素的關係。於2023年在德克薩斯州達拉斯舉辦的ORS骨科研究學會年會上發佈。
  5. Snethen萬., Son, Y., Mueri, C., Bischoff, J. 壓制貼合對無干預肩關節置換術初始穩定性的影響。於2022年在夏威夷毛伊島舉辦的ISTA國際關節置換技術學會年會上發佈。
  6. Snethen萬., Mueri, C., Son, Y., Parisi, R., Duquin萬億. 幾何設計對無干預植入物初始穩定性的影響。已被接受在2025年ORS骨科研究學會年會上發佈;2025年2月7-11日;亞利桑那州鳳凰城。
  7. ZBTR_30118. 齊默巴奧米特內部研究報告存檔。
  8. OsseoTi多孔金屬技術結合解剖數據與3D打印技術,構建出旨在模仿人類松質骨結構的設計。
  9. Gupta, G. 對羊長骨缺損模型中骨生長植入材料的評估 12-04/12-07, 2013年2月。32。
  10. Hamidreza Alidousti, Joshua W Giles, Roger J H Emery, Jonathan Jeffers, 肱骨頭骨密度的空間映射,《肩肘外科雜誌》2017年,卷26,1653-1661。

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SOURCE Zimmer Biomet Holdings, Inc.

信息來源:齊默巴奧米特控股公司。

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