Corin Achieves FDA 510(k) Clearance for New Apollo™ Application, ApolloHipX™

Redefining Precision and Efficiency in Total Hip Arthroplasty (THA)

RAYNHAM, MA, UNITED STATES, January 14, 2025 /EINPresswire.com/ -- Corin, a leading robotics and AI innovator in orthopaedics, has received FDA 510(k) clearance for ApolloHipX™, a next-generation THA application designed for the Corin Apollo™ platform. ApolloHipX™ is the first and only hip arthroplasty technology to integrate dynamic 3D preoperative planning with intraoperative fluoroscopy, enabling surgeons to implement a personalized plan with greater precision and efficiency.

ApolloHipX™ leverages a patented 2D-3D automated registration algorithm to align the preoperative CT scans with intraoperative fluoroscopic images. Unlike current systems that rely on 2D measurements, ApolloHipX™ reconstructs 3D spatial relationships between the implants and bones, providing a more accurate assessment of component position from a single image — independent of patient positioning and C-arm alignment. This results in fewer intraoperative images required, optimizing surgical efficiency and minimizing radiation exposure within the operating room.1

“ApolloHipX™ is a seamless THA solution, bridging 3D preoperative planning and 2D intraoperative fluoroscopy with a focus on precision and simplicity,” said Dr. Jim Pierrepont, Global Franchise Lead at Corin Group. “By leveraging big data from the CorinRegistry™, we continue to develop deep learning models that enhance precision and efficiency across our technology platforms.”

OPSInsight™ provides dynamic 3D preoperative planning for ApolloHipX™, analyzing the spinopelvic relationship to optimize implant positioning. Enhanced with a deep learning model trained on over 50,000 X-ray images from the CorinRegistry™, this algorithm automatically analyzes functional hip-spine X-rays.2 OPSInsight™ seamlessly integrates with ApolloHipX™, automatically uploading surgical plans to the Apollo™ station via the cloud and securely transferring intraoperative images and achieved implant positions to the CorinRegistry™ postoperatively. This data enhances the deep learning models, driving continuous refinement of future planning capabilities.

“As direct anterior approach (DAA) and outpatient procedures continue to increase in popularity, ApolloHipX™ was developed to address market demands for a reliable and efficient clinical solution," said Jon Serbousek, CEO of Corin Group. "This 510(k) clearance underscores our dedication to delivering innovations that solve real clinical challenges. From the outset, the Apollo™ platform has had ambitious milestones, and we’ve consistently delivered, reaffirming Corin’s leadership in advancing orthopaedic technology."

Additional system features include…
• Compatibility with Corin’s full portfolio of clinically proven hip implants, including the new Icona™, a triple-taper, fully coated cementless femoral stem.
• Exclusive integration with OPSInsight™, widely recognized as the gold standard in spinopelvic analysis and functional preoperative planning for THA.
• Automated registration of the preoperative CT eliminates distortion and artifacts typically associated with 2D-only applications.
• Intraoperative “Optimization” feature allows the surgeon to preview leg length and offset values given various head/neck/liner combinations.
• Multi-application capabilities, ApolloKnee™ is the first and only robotic-assisted TKA procedure to provide objective pre-resection balance utilizing gap and load data throughout the full range of motion.

ApolloHipX™ is now available through a limited market release, for more information, please visit www.coringroup.com/ApolloHipX or contact your local Corin representative. Not all products are available or cleared for distribution in all markets.

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 maximize healthcare value for both patients and providers.

References:
1. Plaskos C, Pierrepont J, Shi J, Smith G, Bromwich L, Arulampalam J, Ehlke M, Saxena A, Slotkin EM. Accuracy of 3D/2D Registration for Determining Cup Position and Leg Length in Fluoroscopy Guided THA. ISTA 2024
2. Smith GH, Wakelin EA, Gupta A, Plaskos C, Pierrepont JW. Automated Landmark Detection in Functional Lateral Radiographs Using Deep Learning. ISTA 2023

Molly Maclennan
Corin Group
+1 774-226-1853
media@coringroup.com
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ApolloHipX™ FDA 510(k) clearance announcement