FDA Approval
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Spine
ZimVie Announces FDA Approval to Launch Mobi-C® Hybrid Study
Decision clears the way for enrollment of U.S. patients in a groundbreaking clinical study of cervical arthroplasty adjacent to fusion…
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Extremities
Paragon 28®, Inc. Receives FDA Approval for IDE Feasibility Study of Its SMART Total Talus™ System for use in Conjunction with the APEX 3D™ Total Ankle Replacement System
Paragon 28’s first in the world 3D-printed Patient Specific Talus Spacer. Use in treatment of avascular necrosis (AVN). FDA approval:…
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Regulatory
ZimVie Announces FDA Approval for New Mobi-C® Implant
Smaller height implants in all Mobi-C footprints to address patient anatomy WESTMINSTER, Colo., Aug. 10, 2023 (GLOBE NEWSWIRE) — ZimVie…
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Spine
Globus Medical Announces FDA Approval for its Non-Fusion Scoliosis Correction System, the Latest Advancement for Young Patients with Idiopathic Scoliosis
REFLECT™ is approved through the FDA’s Humanitarian Device Exemption pathway AUDUBON, Pa., May 15, 2023 (GLOBE NEWSWIRE) — Globus Medical,…
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Regulatory
Bioretec is the first in the world to receive FDA approval for a bioresorbable metal product
TAMPERE, Finland, March 30, 2023 /PRNewswire/ — Bioretec Ltd, a pioneer in bioresorbable[1] orthopedic implants, has today announced receiving the market authorization of…
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Recon
LimaCorporate Announces FDA Approval for new “PRIMA” Shoulder Platform Including Short Stem and TT Glenoid
Udine, Italy, Oct. 7, 2022 /PRNewswire/ — LimaCorporate proudly announces the FDA approval of a new shoulder platform focused on versatility and Operating…
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Biologics
Lipogems® Receives IDE Approval From The U.S. FDA To Begin A Pivotal Clinical Study On The Safety And Effectiveness Of The Lipogems System For The Treatment of Knee Osteoarthritis
ATLANTA , June 10, 2022 /PRNewswire/ — Lipogems is pleased to announce the unconditional approval by the U.S. Food and Drug Administration (FDA) to…
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COVID-19
FDA Approves First COVID-19 Vaccine
Approval Signifies Key Achievement for Public Health August 23, 2021 Today, the U.S. Food and Drug Administration approved the first…
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Regulatory
NuVasive’s Simplify Disc Receives FDA Approval for Two-Level Cervical Total Disc Replacement
Simplify® Cervical Artificial Disc achieved the highest overall clinical success rate at both one- and two-levels compared to any other…
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Extremities
Nation’s Top Orthopedic Hospital Launches the First FDA Approved Digital Pathology Platform
NEW YORK, Feb. 9, 2021 /PRNewswire/ –Hospital for Special Surgery (HSS), the world’s leading academic medical center specializing in orthopedics, rheumatology, and related…
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Regulatory
Simplify Medical Announces First Implantation of its Cervical Artificial Disc in the U.S. Following 1-Level Approval from the FDA
SUNNYVALE, Calif., Dec. 16, 2020 (GLOBE NEWSWIRE) — Simplify Medical, Inc., a privately-held company focused on cervical spinal disc arthroplasty and…
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Recon
LimaCorporate Announces FDA Approval for an Ide Study on Smr Stemless Reverse Shoulder System
UDINE, Italy, Nov. 19, 2020 /PRNewswire/ — LimaCorporate is proud to announce that the U.S. Food and Drug Administration (FDA) has approved the…
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Regulatory
FDA Approves joimax® Intracs®em Electromagnetic Navigation System for Endoscopic Minimally Invasive Spine Surgery
August 6, 2020 IRVINE, Calif.–(BUSINESS WIRE)–joimax®, the German-based market leader in technologies and training methods for full-endoscopic and minimally invasive…
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Biologics
Cerapedics Announces FDA approval of an IDE supplement
WESTMINSTER, Colo., July 22, 2020 — Cerapedics, a private ortho-biologics company, today announced the U.S. Food and Drug Administration (FDA)…
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Regulatory
Orthofix Announces FDA Approval of STIM onTrack 2.1 Mobile App for Bone Growth Stimulators
February 13, 2020 LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device company focused on musculoskeletal products and therapies,…
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