Corin Announces FDA 510(k) Clearance for New Icona™ Femoral Stem

RAYNHAM, MASSACHUSETTS, UNITED STATES of AMERICA - 5 November 2024 - Corin, a global leader in orthopaedic innovation, today announced 510(k) clearance for its Icona™ femoral stem. This new collared, metaphyseal-filling, triple-taper stem was designed using comprehensive data from the CorinRegistry™ and represents a significant addition to Corin's portfolio of clinically proven implants for total hip arthroplasty (THA).

"Corin is excited to showcase Icona™ at the AAHKS Annual Meeting in Dallas this week," said Cynthia Ansari, Chief Commercial Officer at Corin USA. "With design features tailored to direct anterior approach (DAA) and streamlined instrumentation for ASCs, Icona™ reflects the implementation of real-world data in innovation. By leveraging anonymized data from technology-enabled procedures, Corin is able to advance technology and implant design."

Designed for efficient, reproducible canal preparation and ease of insertion during muscle-sparing approaches, key features of Icona™ include:

• Reduced proximal lateral shoulder, a swept distal tip, and a 15-degree angled insertion feature
• Reduced shoulder height in smaller sizes, allowing easier insertion around the greater trochanter
• Offset hybrid broaches with combined extraction and compaction tooth geometries to preserve patient anatomy while creating a tapered press-fit region
• Simple, stackable two-tray system with streamlined instrumentation
• Coated with proximal titanium plasma spray and a full calcium phosphate (CaP) layer to enhance fixation and stability

"Using a statistical shape model developed from patient CT scans in the CorinRegistry, we found that neck height from the medial calcar does not increase with internal metaphyseal diameter. Consequently, to avoid over lengthening in larger stems, neck height should grow minimally with increasing implant size, contrary to other common designs," said Dr. Christopher Plaskos, VP of Global Clinical Innovation at Corin. These findings were recently presented at the 2024 ISTA meeting in Nashville, TN, USA.

The Icona™ stem fully integrates with Corin's OPSInsight™ technology, recently achieving a milestone of 50,000 procedures. OPSInsight™ is a dynamic analysis designed to optimize implant position, stability, and patient outcomes by preoperatively assessing individual spinopelvic mobility and biomechanics. Icona™ is also forward-compatible with Corin's planned advancements in hip technology.

Icona™ is exclusively available in the United States through a limited market release. For more information, please visit www.coringroup.com/ or contact your local Corin representative.

2024 American Academy of Hip and Knee Arthroplasty Surgeons (AAHKS) Annual Meeting attendees can see Icona™ later this week at the Corin booth (1318), along with Corin's full range of implants and connected technologies.

About Corin

Corin is a fast-growing global leader in orthopaedic innovation, with a vision to revolutionize the field. By integrating advanced robotic and AI technologies for planning, implementation, and continuous learning with its clinically proven implants, Corin strives to maximizes healthcare value for both patients and providers.