{"id":62701,"date":"2026-02-25T16:06:03","date_gmt":"2026-02-25T15:06:03","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/catalyst-orthoscience-announces-fda-510k-clearance-of-archer-patient-specific-instrumentation-for-shoulder-arthroplasty\/"},"modified":"2026-02-25T16:06:03","modified_gmt":"2026-02-25T15:06:03","slug":"catalyst-orthoscience-announces-fda-510k-clearance-of-archer-patient-specific-instrumentation-for-shoulder-arthroplasty","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/catalyst-orthoscience-announces-fda-510k-clearance-of-archer-patient-specific-instrumentation-for-shoulder-arthroplasty\/","title":{"rendered":"Catalyst OrthoScience Announces FDA 510(k) Clearance of Archer\u00ae Patient-Specific Instrumentation for Shoulder Arthroplasty"},"content":{"rendered":"
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\nNew patient-specific solution expands Catalyst\u2019s portfolio, enabling precise translation of 3D surgical plans into the operating room to reduce steps and increase accuracy<\/i><\/p>\n

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NAPLES, Fla.–(BUSINESS WIRE)–Catalyst OrthoScience Inc.<\/a> (\u201cCatalyst\u201d), a private medical technology company redefining shoulder arthroplasty through simplified, surgeon-focused innovation, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its Archer\u00ae Patient-Specific Instrumentation (PSI). Licensed in partnership with 3D-Side, Archer PSI is a full suite of humeral and glenoid guides tailored to the patient\u2019s anatomy that allow orthopedic surgeons to execute their 3D preoperative plans intraoperatively with greater precision, consistency, and confidence. Catalyst is one of the only companies to offer patient-specific guides for both the glenoid and humerus.<\/p>\n

\nUsed in combination with the Archer\u00ae 3D Planning Software, Archer PSI enhances preoperative planning accuracy and supports intraoperative efficiency. Archer PSI is indicated for anatomic and reverse procedures, enabling surgeons to personalize humeral and glenoid implant positioning while maintaining a streamlined surgical workflow.<\/p>\n

\n\u201cAs the demand for enabling technologies continues to build, the Archer PSI system is yet another milestone in our commitment to delivering meaningful clinical and operational value to surgeons,\u201d said Ephraim Akyuz, PhD, chief technology officer at Catalyst. \u201cThe addition of PSI to the Archer 3D planning system allows surgeons to now execute more accurately to their pre-operative plans while reducing the number of procedural steps and saving valuable operative time.\u201d<\/p>\n

\nCatalyst has initiated a limited market release (LMR) of Archer PSI with select surgeon partners, including use of Archer PSI in anatomic and reverse cases. Insights gathered during LMR will help guide final product optimization ahead of a broader commercial launch.<\/p>\n

\n\u201cArcher PSI integrates seamlessly into my surgical workflow and minimizes the risk of improper implant positioning,\u201d said Dr. Matthew Kippe, a participating LMR surgeon\/one of the Archer design surgeons. \u201cThe ability to plan cases in advance and execute with patient-specific guides, tailored to each person\u2019s anatomy is extremely beneficial, especially in complex anatomy, and I look forward to contributing feedback as Catalyst prepares for full commercial release.\u201d<\/p>\n

\nAbout Catalyst OrthoScience Inc.<\/b><\/p>\n

\nCatalyst OrthoScience, founded in 2014 by orthopedic surgeon Dr. Steven Goldberg and based in Naples, Fla., is redefining shoulder replacement surgery. With a focus on less invasive techniques, fewer complications, and a more natural-feeling shoulder, Catalyst is breaking away from traditional approaches. Our total shoulder systems are engineered for precision and efficiency \u2013 preserving bone and soft tissue while enabling delivery of consistent, reproducible results. With a growing portfolio of issued and pending patents, Catalyst technology is available across the U.S. Learn more at www.catalystortho.com<\/a> and connect with us on LinkedIn<\/a>.<\/p>\n

\nAbout 3D-Side S.A.<\/b><\/p>\n

\n3D-Side is a Belgian medtech company founded in 2015, and offers customizable software and additive manufacturing technology to assist with complex bone surgery. From images to 3D printing, the company offers advanced tools for planning, team communication, and manufacturing of patient specific medical devices. For more information, visit www.3d-side.com<\/a>.<\/p>\n

Contacts<\/b> <\/p>\n

\nNicole Nelson
\n
Media Relations
\n
(239) 325-9976<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

New patient-specific solution expands Catalyst\u2019s portfolio, enabling precise translation of 3D surgical plans into the operating room to reduce steps and increase accuracy NAPLES, Fla.–(BUSINESS WIRE)–Catalyst OrthoScience Inc. (\u201cCatalyst\u201d), a private medical technology company redefining shoulder arthroplasty through simplified, surgeon-focused innovation, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its Archer\u00ae Patient-Specific … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-62701","6":"format-standard","7":"category-industry"},"yoast_head":"\nCatalyst OrthoScience Announces FDA 510(k) Clearance of Archer\u00ae Patient-Specific Instrumentation for Shoulder Arthroplasty - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/catalyst-orthoscience-announces-fda-510k-clearance-of-archer-patient-specific-instrumentation-for-shoulder-arthroplasty\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Catalyst OrthoScience Announces FDA 510(k) Clearance of Archer\u00ae Patient-Specific Instrumentation for Shoulder Arthroplasty - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"New patient-specific solution expands Catalyst\u2019s portfolio, enabling precise translation of 3D surgical plans into the operating room to reduce steps and increase accuracy NAPLES, Fla.–(BUSINESS WIRE)–Catalyst OrthoScience Inc. 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