https://www.orthoworld.com ORTHOWORLD JULIE A. VETALICE Catalyst OrthoScience Receives FDA 510(k) Clearance of its Reverse Shoulder ... Catalyst OrthoScience Receives FDA 510(k) Clearance of its Reverse Shoulder System Catalyst can now address stemless anatomic and reverse TSA, the two fastest growing segments of the shoulder replacement market. Read more
https://www.orthoworld.com ORTHOWORLD JULIE A. VETALICE FDA Issues Safety Communication on STAR Ankle FDA Issues Safety Communication on STAR Ankle The notice relates to a higher than expected risk of fracture in the device's plastic component, as early as 3 to 4 years post-implantation. Read more
https://www.orthoworld.com ORTHOWORLD JULIE A. VETALICE Conformis Gains Clearance for iTotal PS Knee in Australia Conformis Gains Clearance for iTotal PS Knee in Australia iTotal PS patient-specific implants fit the size and shape of each patient's knee, and provide stability throughout the full range of motion. Read more
https://www.orthoworld.com ORTHOWORLD JULIE A. VETALICE FDA Clearance for G21 SpaceFlex Shoulder FDA Clearance for G21 SpaceFlex Shoulder The SpaceFlex Shoulder is now available in the U.S., joining G21's hip and knee modular spacer mold systems. Read more
https://www.orthoworld.com ORTHOWORLD JULIE A. VETALICE Episurf Medical Plans to Submit Patellofemoral System for 510(k) Episurf Medical Plans to Submit Patellofemoral System for 510(k) The application for the two-component patellofemoral implant is slated for filing in 2021, followed by launch in 2022. Read more
https://www.orthoworld.com ORTHOWORLD JULIE A. VETALICE FX Solutions Gains FDA Clearance for Easytech Stemless Anatomic Shoulder FX Solutions Gains FDA Clearance for Easytech Stemless Anatomic Shoulder Easytech is the only primary peripheral fitting anatomic stemless shoulder on the market. Read more
https://www.orthoworld.com ORTHOWORLD JULIE A. VETALICE FDA Approves Additive Orthopaedics’ Patient Specific Talus Spacer FDA Approves Additive Orthopaedics’ Patient Specific Talus Spacer Additive Orthopaedics received an approval order for its Humanitarian Device Exemption application for treatment of avascular necrosis. Read more
https://www.orthoworld.com ORTHOWORLD JULIE A. VETALICE Medacta Gains Clearance for Total Hip Planning Tools Medacta Gains Clearance for Total Hip Planning Tools MyHip Planner and MyHip Verifier are personalized solutions used in primary total hip replacement. Read more
https://www.orthoworld.com ORTHOWORLD JULIE A. VETALICE LimaCorporate Gains Regulatory Approvals for Smart SPACE Digital Platform LimaCorporate Gains Regulatory Approvals for Smart SPACE Digital Platform The Smart SPACE digital platform features novel orthopedic technology and a pipeline of landscape-changing applications for the shoulder. Read more
https://www.orthoworld.com ORTHOWORLD JULIE A. VETALICE BioPoly Gains FDA Clearance of Great Toe Implant BioPoly Gains FDA Clearance of Great Toe Implant With this FDA clearance, BioPoly technology is available for the first time in the U.S. Read more