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First Subjects Randomized in Clinical Trial Evaluating the Benefits of Total Segmental Fusion in Treating Degenerative Conditions in the Lumbar SpineFziomed Announces Clinical Results from Level I Study Evaluating Oxiplex Absorbable Gel for Spine SurgeryOSSIOfiber® Minimally Invasive All-Natural Bunion Correction System Improves, Simplifies Surgical Procedure for Patients and Physicians
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FDA clearances, PMA approvals, product recalls, litigation, and the regulatory landscape shaping orthopaedic devices.

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Top Legal & Regulatory Stories
SpinePoint Receives U.S. FDA 510(k) Clearance for Flex-Z™ Cervical Cage / First Product in the Ultra-Low Stiffness Cushioning Interbody Platform

SpinePoint Receives U.S. FDA 510(k) Clearance for Flex-Z™ Cervical Cage / First Product in the Ultra-Low Stiffness Cushioning Interbody Platform

SpinePoint LLC announced U.S. FDA 510(k) clearance of the Flex-Z™ Cervical Cage (K252432) on March 25, 2026.

halvorsonMar 28, 2026
Spinal Elements Expands Ventana® Platform with FDA 510(k) Clearance and First Cases of Ventana® A ALIF System

Spinal Elements Expands Ventana® Platform with FDA 510(k) Clearance and First Cases of Ventana® A ALIF System

halvorsonMar 19, 2026
2nd FDA Clearance for Novel Instrument Sterilization System

2nd FDA Clearance for Novel Instrument Sterilization System

elizabethhofheinzmedmphMar 2, 2026
FDA Approves (PMA) Dynamic Sagittal Tethering for Spondy

FDA Approves (PMA) Dynamic Sagittal Tethering for Spondy

elizabethhofheinzmedmphMar 2, 2026
More in Legal & Regulatory
Synergy Spine Solutions® Receives FDA Approval for its Synergy Disc®, Expanding Cervical Disc Replacement Options for U.S. Patients

Synergy Spine Solutions® Receives FDA Approval for its Synergy Disc®, Expanding Cervical Disc Replacement Options for U.S. Patients

halvorsonFeb 27, 2026
4WEB Medical Receives 510(k) Clearance to Market its New SI Joint Truss System™

4WEB Medical Receives 510(k) Clearance to Market its New SI Joint Truss System™

halvorsonFeb 25, 2026
MiRus® Receives FDA 510(k) Clearance for IO™ Expandable Wedge Osteotomy System

MiRus® Receives FDA 510(k) Clearance for IO™ Expandable Wedge Osteotomy System

halvorsonFeb 24, 2026

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Latest Legal & Regulatory Articles
FDA Clears IST’s ONE TRAY® for 365 Day Storage, Expanding Sterilization Flexibility for Surgical Facilities

FDA Clears IST’s ONE TRAY® for 365 Day Storage, Expanding Sterilization Flexibility for Surgical Facilities

ONE TRAY®s NEW additional clearance in 2025 (IFU K250029**) maintains the same validated sterilization parameters – 270°F (132°C), Exposure Time 4 minutes, but with a 365 day event related shelf life/storage period with a 15-minute minimum dry time.

halvorsonFeb 20, 2026
Medtronic’s Next Gen Intelligent Spine Platform Unveiled

Medtronic’s Next Gen Intelligent Spine Platform Unveiled

Spine surgeons, gather ‘round — there’s a new system in town…and it’s not just another robot arm bolted onto a navigation cart.

elizabethhofheinzmedmphFeb 19, 2026
Medtronic Announces FDA approval of Infuse™ bone graft for one-and-two level Transforaminal Lumbar Interbody Fusion (TLIF) spine procedures

Medtronic Announces FDA approval of Infuse™ bone graft for one-and-two level Transforaminal Lumbar Interbody Fusion (TLIF) spine procedures

Infuse™ is the only PMA-approved growth factor bone graft indicated for ALIF, OLIF, and TLIF.

halvorsonFeb 17, 2026
Medtronic receives FDA clearance for Stealth AXiS™ surgical system, first integrated planning, navigation and robotics platform for spine surgery

Medtronic receives FDA clearance for Stealth AXiS™ surgical system, first integrated planning, navigation and robotics platform for spine surgery

Medtronic today announced U.S. Food and Drug Administration (FDA) clearance of the Stealth AXiS™ surgical system.

halvorsonFeb 13, 2026
Patent Granted for Artificially Intelligent Surgical Planning

Patent Granted for Artificially Intelligent Surgical Planning

AI ortho software patent granted to 1-year old, Gainesville, Florida-based Advita Ortho.

elizabethhofheinzmedmphFeb 13, 2026
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