This section highlights FDA-related milestones and regulatory updates for drugs developed by Smith & Nephew SNATS (SNN).
Over the past two years, Smith & Nephew SNATS has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
CATALYSTEM and LEGION. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
CATALYSTEM - FDA Regulatory Timeline and Events
CATALYSTEM is a drug developed by Smith & Nephew SNATS for the following indication: Primary Hip System.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CATALYSTEM
- Announced Date:
- September 18, 2024
- Indication:
- Primary Hip System.
Announcement
Smith+Nephew announces promising surgeon feedback from the first completed cases utilizing its new CATALYSTEM Primary Hip System.
AI Summary
Smith+Nephew recently announced promising feedback from surgeons who performed the first completed cases using its new CATALYSTEM Primary Hip System. This innovative system, designed with a triple-taper stem and uniform proximal loading, offers a reduced distal geometry and shorter lengths that make it especially suitable for anterior approach hip surgeries while remaining versatile for other procedures. Surgeons from well-known US hospitals provided positive remarks about their initial experiences. Dr. Thorsten Seyler from Duke University highlighted the system’s advanced technology and patient personalization, noting it represents the beginning of a new era in hip replacement. Other surgeons praised the system's user-friendly instruments and the precision it offers, with enhanced cutting performance and better rotational stability. Their positive comments suggest that this new hip system may improve outcome predictability and reproducibility, potentially raising the standard of care in hip arthroplasty.
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LEGION Hinged Knee (HK) System - FDA Regulatory Timeline and Events
LEGION Hinged Knee (HK) System is a drug developed by Smith & Nephew SNATS for the following indication: To provide a natural range of motion with medial pivot, lateral roll back, and screw home.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LEGION Hinged Knee (HK) System
- Announced Date:
- October 2, 2024
- Indication:
- To provide a natural range of motion with medial pivot, lateral roll back, and screw home.
Announcement
Smith+Nephew announced that that its LEGION Hinged Knee (HK) System is now available in the United States with proprietary OXINIUM (Oxidized Zirconium) implant technology that delivers the durability of metals, the wear resistance of ceramics, and corrosion resistance better than both.1-11
AI Summary
Smith+Nephew has announced that its LEGION Hinged Knee (HK) System is now available in the United States, featuring the company’s proprietary OXINIUM (Oxidized Zirconium) implant technology. This breakthrough technology combines the durability of metals with the wear resistance of ceramics while offering superior corrosion resistance compared to both. The advanced material is designed to help reduce risks associated with knee revision procedures, providing improved long-term performance.
The LEGION HK System, part of the LEGION Total Knee System, is engineered to deliver a natural range of motion with features such as a medial pivot, lateral rollback, and screw home mechanism. With its innovative OXINIUM Technology, the system supports surgeons in performing stable reconstructions even in complex cases, setting a new standard for knee revision surgery and enhancing patient outcomes.
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