Corin Receives FDA Clearance for Icona Femoral Stem in Total Hip Arthroplasty
核心洞察
Corin gains FDA 510(k) clearance for the Icona™ femoral stem (搜索), designed using data from the CorinRegistry™ for total hip arthroplasty (THA).
The Icona™ stem features design elements tailored for direct anterior approach (DAA) and streamlined instrumentation for ambulatory surgery centers (ASCs).
Icona™ integrates with Corin's OPSInsight™ technology, which optimizes implant position and patient outcomes through preoperative spinopelvic mobility assessment.
Corin, a global leader in orthopaedic innovation, has announced FDA 510(k) clearance for its Icona™ femoral stem (搜索). The 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).
Data-Driven Design
According to Cynthia Ansari, Chief Commercial Officer at Corin USA, Icona™ will be showcased at the AAHKS Annual Meeting in Dallas. The design features are tailored to direct anterior approach (DAA) and streamlined instrumentation for ASCs, reflecting the implementation of real-world data in innovation. By leveraging anonymized data from technology-enabled procedures, Corin aims to advance technology and implant design.
Key Features of Icona™
The Icona™ stem is designed for efficient, reproducible canal preparation and ease of insertion during muscle-sparing approaches. Key features 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.
Statistical Shape Modeling
Dr. Christopher Plaskos, VP of Global Clinical Innovation at Corin, explained that a statistical shape model developed from patient CT scans in the CorinRegistry indicated that neck height from the medial calcar does not increase with internal metaphyseal diameter. This finding suggests that neck height should grow minimally with increasing implant size to avoid over lengthening in larger stems, contrary to other common designs. These findings were recently presented at the 2024 ISTA meeting in Nashville, TN, USA.
Integration with OPSInsight™ Technology
The Icona™ stem fully integrates with Corin’s OPSInsight™ technology, which recently achieved 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.
Availability
The Icona™ stem is exclusively available in the United States through a limited market release. For more information, visit www.coringroup.com or contact your local Corin representative.