Legal & Regulatory and Reimbursement Archives

Legal & Regulatory and Reimbursement

Zimmer Biomet Receives FDA Clearance for Expanded Reverse Shoulder Systems

by TJ Halvorson April 17, 2026April 17, 2026

Legal & Regulatory and Reimbursement

SurGenTec Secures FDA 510(k) Clearance for TiLink™ SI joint fusion- Now Navigation Compatible

by TJ Halvorson April 15, 2026April 15, 2026

Legal & Regulatory and Reimbursement

CarboFix Spine Announces FDA Clearance of CarboClear® Hybrid Posterior Cervical Screw System

by Carl Stearns April 15, 2026April 24, 2026

Extremities

Biodynamik Receives FDA IDE Approval for Pivotal U.S. Trial of XT3 System in Diabetic Foot Ulcers

by TJ Halvorson April 7, 2026April 7, 2026

Spine

Orthomod Announces FDA Clearance of MOD-C™ Cervical Implant, Debuting Novel CAMP™ Biomaterial

by TJ Halvorson April 7, 2026April 24, 2026

Legal & Regulatory and Reimbursement

Highridge Medical Announces Landmark Positive Policy Decision for The Tether™ Vertebral Body Tethering System

by TJ Halvorson April 1, 2026April 1, 2026

Legal & Regulatory and Reimbursement

Spectrum Spine Inc Earns FDA Clearance for Next Generation Nanotechnology – BioBraille™

by TJ Halvorson April 1, 2026April 1, 2026

Legal & Regulatory and Reimbursement

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

by TJ Halvorson March 28, 2026March 28, 2026

Legal & Regulatory and Reimbursement

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

by TJ Halvorson March 19, 2026March 19, 2026

Legal & Regulatory and Reimbursement

2nd FDA Clearance for Novel Instrument Sterilization System

by Elizabeth Hofheinz, M.P.H., M.Ed. March 2, 2026March 5, 2026

Legal & Regulatory and Reimbursement

FDA Approves (PMA) Dynamic Sagittal Tethering for Spondy

by Elizabeth Hofheinz, M.P.H., M.Ed. March 2, 2026February 27, 2026

Legal & Regulatory and Reimbursement

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

by TJ Halvorson February 27, 2026February 27, 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

Legal & Regulatory and Reimbursement

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

by TJ Halvorson February 25, 2026February 25, 2026

Legal & Regulatory and Reimbursement

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

by TJ Halvorson February 24, 2026February 24, 2026

Legal & Regulatory and Reimbursement

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

by TJ Halvorson February 20, 2026February 20, 2026

Legal & Regulatory and Reimbursement

Medtronic’s Next Gen Intelligent Spine Platform Unveiled

by Elizabeth Hofheinz, M.P.H., M.Ed. February 19, 2026February 18, 2026

Legal & Regulatory and Reimbursement

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

by TJ Halvorson February 17, 2026February 18, 2026

Legal & Regulatory and Reimbursement

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

by TJ Halvorson February 13, 2026February 18, 2026

Legal & Regulatory and Reimbursement

Patent Granted for Artificially Intelligent Surgical Planning

by Elizabeth Hofheinz, M.P.H., M.Ed. February 13, 2026March 6, 2026

Legal & Regulatory and Reimbursement

Medtronic Tagged for $380 Million – a Warning to Others?

by Robin Young February 9, 2026February 9, 2026

Legal & Regulatory and Reimbursement

Mainstay Medical Announces Exclusive Coverage of ReActiv8® by Blue Cross Blue Shield of North Dakota

by TJ Halvorson February 6, 2026February 6, 2026

Legal & Regulatory and Reimbursement

First-of-its-kind Universal Clearance Establishes Maximum Regulatory Access to the Bezier Parametric Curve Spinal Rod System for Patients and Surgeons

by TJ Halvorson February 6, 2026February 6, 2026

Legal & Regulatory and Reimbursement

FDA Clears a Smarter Knee: Which Knows How You Like to Operate

by Kim DelMonico February 2, 2026February 4, 2026

Legal & Regulatory and Reimbursement

QuadLock™ Enters the Chat: ACL Fixation That Doesn’t Budge

by Elizaabeth Hofheinz, M.P.H., M.Ed. January 30, 2026January 30, 2026

Legal & Regulatory and Reimbursement

Spine Innovation Announces FDA 510(k) Clearance for LOGIC™ Titanium Expandable Interbody System

by TJ Halvorson January 27, 2026January 27, 2026

Legal & Regulatory and Reimbursement

BlueOcean Global Announces FDA 510(k) Clearance of the Excelsior™ External Fixation System

by TJ Halvorson January 26, 2026February 13, 2026

Legal & Regulatory and Reimbursement

Notice of Allowability Issued for Variable-Dimension Fixation Rod and Implantable Stabilization System Expanding Use Specific to Patient Anatomy

by TJ Halvorson January 22, 2026January 22, 2026

Legal & Regulatory and Reimbursement

Spark Spine Secures Core Intellectual Property with Notice of Allowance for EMP Technology

by TJ Halvorson January 22, 2026January 22, 2026

Category: Legal & Regulatory and Reimbursement

Zimmer Biomet Receives FDA Clearance for Expanded Reverse Shoulder Systems

SurGenTec Secures FDA 510(k) Clearance for TiLink™ SI joint fusion- Now Navigation Compatible

CarboFix Spine Announces FDA Clearance of CarboClear® Hybrid Posterior Cervical Screw System

Biodynamik Receives FDA IDE Approval for Pivotal U.S. Trial of XT3 System in Diabetic Foot Ulcers

Orthomod Announces FDA Clearance of MOD-C™ Cervical Implant, Debuting Novel CAMP™ Biomaterial

Highridge Medical Announces Landmark Positive Policy Decision for The Tether™ Vertebral Body Tethering System

Spectrum Spine Inc Earns FDA Clearance for Next Generation Nanotechnology – BioBraille™

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

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

2nd FDA Clearance for Novel Instrument Sterilization System

FDA Approves (PMA) Dynamic Sagittal Tethering for Spondy

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

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

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

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

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

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

Medtronic’s Next Gen Intelligent Spine Platform Unveiled

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

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

Patent Granted for Artificially Intelligent Surgical Planning

Medtronic Tagged for $380 Million – a Warning to Others?

Mainstay Medical Announces Exclusive Coverage of ReActiv8® by Blue Cross Blue Shield of North Dakota

First-of-its-kind Universal Clearance Establishes Maximum Regulatory Access to the Bezier Parametric Curve Spinal Rod System for Patients and Surgeons

FDA Clears a Smarter Knee: Which Knows How You Like to Operate

QuadLock™ Enters the Chat: ACL Fixation That Doesn’t Budge

Spine Innovation Announces FDA 510(k) Clearance for LOGIC™ Titanium Expandable Interbody System

BlueOcean Global Announces FDA 510(k) Clearance of the Excelsior™ External Fixation System

Notice of Allowability Issued for Variable-Dimension Fixation Rod and Implantable Stabilization System Expanding Use Specific to Patient Anatomy

Spark Spine Secures Core Intellectual Property with Notice of Allowance for EMP Technology

The Promise of Biomimetic Implant Surfaces & Nano + Femtosecond Laser Texturing

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