Restor3d Receives FDA 510(k) Clearance for Axiom PSR, a 3D-Printed, Patient-Specific Metal Instrumentation System for Total Ankle Replacement
Apr 07, 2023 15:58
CST Updated
15:58
Restor3d
3D Printing Implant Supplier
FDA
U.S. Food and Drug Administration
△ Manufactured by Restor3d for ankle jointsSurgery3D Printing of Restor3dImplant
The Latest Member of 3D-Printed Orthopedic Implants
The Axiom PSR system is the latest addition to Restor3d's lower extremity product portfolio, manufactured additively with titanium alloy and integrating TIDAL technology’s interconnected porosity. This is the first all-metal, patient-specific instrumentation system approved for use with an ankle replacement system.
The system consists of multiple product components, including the Kinos Axiom Total Ankle System, TIDAL Osteotomy Wedge System, and MTP Femoral Head Replacement System, as well as for the r3id personalized surgical platform. The integration of these components enables the Axiom PSR system to provide more precise total ankle surgeries and allows for personalized design and operation based on each patient’s unique condition.
△Restor3d's 3D-Printed Ankle Implant
Axiom PSR All-Metal Ankle Surgery System
According to the company, the Kinos Axiom system is designed for surgical use.SurgeryDesigned in collaboration with doctors to provide precision, accuracy, and efficiency for total ankle arthroplasty.
The all-metal resection guide is 3D printed at the Restor3d facility in Durham, North Carolina, ensuring an ideal anatomical fit and accurate placement of the pre-planned incisions required for the Kinos Axiom Total Ankle System implants. The system’s streamlined design focuses on reducing operative time during total ankle arthroplasty.
Axiom PSR Guide Utilizes Proprietary Surface Topography to Enhance Stability at the Bone-Contact Interface. The Fully Metallic Resection Guide Also Incorporates Radiographic Markers for Ease of Fluoroscopic Visualization, and Its Compact Footprint Helps Minimize Soft Tissue Damage.
△Restor3d Adopts Kinos Axiom Total Ankle System for Treating Ankle Arthritis
"Compared to previous polymer patient-specific instruments, the Axiom PSR Metal Resection Guide offers improved bone positioning and better control over the saw path," said Louisville Orthopedic Clinic.MedicineDr. John Lewis stated that placing the PSR on the bone and performing cuts through the guide gives him more confidence in achieving repeatable cuts during total ankle arthroplasty, while also reducing his time in the operating room. Additionally, the guide integrates radiographic markers and offers the advantage of a minimal footprint to reduce soft tissue disruption.
Brian Garvey, Senior Vice President of Product Development at Restor3d, added: "We are extremely excited to have obtained the first 510(k) clearance for a full-metal, patient-specific joint replacement instrument system with our team. Our in-house 3D printing capabilities, advanced engineering expertise, and...Clinical"The collaboration with key research teams enables us to deliver the next generation of patient-specific devices. Axiom PSR is an excellent addition to Kinos Axiom's total ankle product portfolio, while laying the foundation for other patient-specific development projects we plan to launch in the near future."
Axiom PSR will launch a trial version in April this year and officially go on the market in June 2023.
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