FDA 510(k) clearance Archives - Orthopedics This Week

Legal & Regulatory and Reimbursement

Avatar Medical Receives FDA 510(k) Clearance for Avatar Medical Vision, the First Software Cleared for Use with Glasses-Free 3D Medical Displays

by TJ Halvorson April 28, 2026April 29, 2026

Large Joints and Extremities

Pixee Medical Announces FDA 510(k) Clearance for Its Next-generation Solution, Knee+ NexSight, on a New Augmented Reality Platform

by TJ Halvorson April 27, 2026April 27, 2026

Large Joints and Extremities

FDA Approves Expanded Clinical Applications for SINEFIX™ in Soft Tissue Repair

by TJ Halvorson April 21, 2026April 22, 2026

University Of Utah Orthopaedic Innovation Center Announces FDA Clearance of Breakthrough Dynamic Compression Implant System

by TJ Halvorson April 21, 2026April 24, 2026

Legal & Regulatory and Reimbursement

Kneevoice Receives FDA 510(k) Clearance for Innovative Cartilage Auscultation System

by TJ Halvorson February 27, 2026February 27, 2026

Legal & Regulatory and Reimbursement

Catalyst OrthoScience Announces FDA 510(k) Clearance of Archer® Patient-Specific Instrumentation for Shoulder Arthroplasty

by TJ Halvorson February 26, 2026February 26, 2026