Corin Snags FDA Clearance for its New Icona Femoral Stem

The U.S. Food and Drug Administration has granted 510(k) clearance to Corin’s new metaphyseal-filling, triple-layer Icona femoral stem.

The collared stem was designed using comprehensive data from the CorinRegistry and represents a significant addition to Corin’s total hip arthroplasty (THA) portfolio, executives said.

“With design features tailored to direct anterior approach and streamlined instrumentation for ASCs, Icona reflects the implementation of real-world data in innovation,” Corin USA Chief Commercial Officer Cynthia Ansari stated. “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:

• A 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
• A 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,” Corin Vice President of Global Clinical Innovation Dr. Christopher Plaskos remarked.

The Icona stem fully integrates with Corin’s OPSInsight technology, recently achieving a milestone of 50,000 procedures. OPSInsight is an 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.

Corin offers a combination of clinically-proven hip, knee, ankle, and shoulder solutions and technologies for patients, surgeons, and healthcare providers. By integrating advanced robotic and artificial intelligence technologies for planning, implementation, and continuous learning with its clinically proven implants, Corin strives to maximize healthcare value for both patients and providers.