Testing and Regulatory Landscape for Additively Manufactured Devices—An Orthopedic Innovators Q&A
Uncertainty in proper procedures has left orthopedic device manufacturers seeking answers.
Regulatory & Legal
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Bracing/Prosthetics
Orthotic Brace Suppliers Convicted in $6.5M Fraud Scheme
Each defendant faces up to 55 years in prison.Sam Brusco, Associate Editor 05.18.22
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3-D Printing/Additive Mfg.
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Extremities
Extremity Medical Files Patent Suit Against Fusion Orthopedics
Company alleges infringement on patent for its intraosseous fixation platformSam Brusco, Associate Editor 04.29.22
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Extremities
Extremity Medical Files Patent Suit Against Zimmer Biomet, Nextremity
Firm alleges the companies infringed on a patent for its intraosseous fixation platform.Sam Brusco, Associate Editor 04.06.22
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Extremities
Treace Medical Files Patent Suit Against Fusion Orthopedics
Treace alleges multiple patent infringements related to its Lapiplasty 3D Bunion Correction system.Sam Brusco, Associate Editor 03.29.22
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Large Joint
Exactech Sued for Defective Hip Implant
Company is accused of misrepresenting its implant's polyethylene liner to have a lower wear rate.Sam Brusco, Associate Editor 02.16.22
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Advice for a Successful Medical Device Global Registration Plan
One of the most powerful communication tools available to those responsible for placing medical devices on the market is a global registration plan.Kara Budor, M.S., Senior Manager, International Regulatory Affairs, MCRA LLC 02.14.22
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Globus Accuses Medtronic and Former Employees of Stealing Business
Globus claims $2.5 million in business losses since defendants' resignations.Sam Brusco, Associate Editor 02.02.22
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Spine/Neurology
Nevro, Nalu Medical Settle SCS Patent Suit
Ongoing litigation dismissed; Nalu Medical no longer offering a high-frequency SCS therapy.PR Newswire 12.22.21
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Ship Hold Lifted for NuVasive's Titanium-Based Precice Devices
The company issued an updated field safety notice; IFU updated.Sam Brusco, Associate Editor 12.07.21
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AAOS Releases Pain Alleviation Clinical Practice Guidelines
Guidance is intended to minimize the use of opioids in the post-operative period for better patient outcomes.American Academy of Orthopaedic Surgeons 12.02.21
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MDR Finally Arrives, but Challenges Follow—2021 Year in Review
Resolving these challenges is critical to ensuring the MDR ship remains aloft and capable of fostering product innovation.Michael Barbella, Managing Editor 11.17.21
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FDA Regulatory Challenges for Antimicrobial Orthopedic Devices
Preventing and managing orthopedic-associated infections is one of the major challenges in orthopedic surgery.Mehdi Kazemzadeh-Narbat, Ph.D., Associate Director, Regulatory Affairs, MCRA LLC 11.17.21
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EU MDR Interpretation and Understanding—Devil in the Details
While the date to conform to all transitional requirements has passed, a new wave of scrutiny will arrive as organizations seek certification under the new MDR.Bryan Brosseau, Founder and Principal Consultant, Brosseau Consulting LLC 11.17.21
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Biden to Nominate Dr. Robert Califf for FDA Head
Califf brings nearly four decades of experience as a doctor, researcher, leader & public servant, including previous service as FDA commissioner.The White House 11.15.21
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Arthrex to Pay $16 Million to Resolve Kickback Allegations
Company was accused of paying Colorado surgeon to use and recommend its products.U.S. Department of Justice 11.09.21
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Spine/Neurology
Update on Nevro's Patent Litigation with Boston Scientific
Nevro infringed two Boston Scientific patents; jury awarded Boston Scientific $20 million.PR Newswire 11.02.21
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Spine/Neurology
Life Spine Responds to Globus IP Lawsuit
CEO Michael Butler: “We will vigorously defend our company against Globus’s claims.”Business Wire 10.18.21
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Spine/Neurology
Globus Sues Life Spine for Interbody Spacer IP Infringement
Alleges patent infringement related to Globus’ expandable interbody spacer technology.GlobeNewswire 10.14.21
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Large Joint
Settlement Approved in DePuy Synthes ASR Hip Implant Class Action
$15.5 million CDN settlement fund will be used to pay compensation.PR Newswire 10.04.21
