medical device guru

Orthopedics and Spine

Catalyst Receives FDA 510(k) Clearance for its Convertible Stemmed Total Shoulder Arthroplasty System

Catalyst OrthoScience Inc. (Catalyst), a medical device company focused on the upper extremity orthopedics market, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its fully convertible stemmed total shoulder arthroplasty system with an ellipsoid...

February 10, 2023

Orthopedics and Spine

Globus Medical and NuVasive to Combine in All-Stock Transaction to Create Innovative Global Musculoskeletal Company Focused on Patient Care

Globus Medical (NYSE: GMED), a leading musculoskeletal solutions company, and NUVASIVE (NASDAQ: NUVA), the leader in spine technology innovation, today announced they have entered into a definitive agreement to combine in an all-stock transaction. The transaction brings together two well-regarded...

February 9, 2023

Orthopedics and Spine

Tyber Medical LLC Acquires ADSM-Synchro Medical

Tyber Medical LLC has acquired 100 percent of the capital of ADSM-Synchro Medical, a French orthopedic medical device company, specializing in the development and distribution of implants dedicated to treating surgical forefoot pathologies. Founded in 2010, ADSM has become a...

February 2, 2023

Orthopedics and Spine

Conventus Flower Orthopedics Announces Expansion of its Flex-Thread™ Technology Platform with FDA Clearance of the Ulna Intramedullary Nail System

Conventus Flower Orthopedics, an innovation-driven medical technology company, announced they have received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Flex-Thread™ Ulna Intramedullary (IM) Nail System. The Flex-Thread Ulna Nail marks a new application and portfolio expansion to...

January 19, 2023

Orthopedics and Spine

Hip Innovation Technology Announces Initiation of FDA Approved Investigational Device Exemption Study

Hip Innovation Technology, LLC (HIT), a medical device company developing innovative orthopaedic device solutions to advance the quality of life and quality of care for patients, is pleased to announce the first U.S. implantation of the HIT Reverse Hip Replacement...

January 13, 2023

Orthopedics and Spine

Empirical Spine Completes Full Premarket Approval (PMA) Submission to FDA for Limiflex™ Dynamic Sagittal Tether™

Empirical Spine, Inc., a medical device company creating a new class of spinal implant, recently completed the final step in the U.S. Food & Drug Administration (FDA) submission process for the LimiFlex™ Dynamic Sagittal Tether™ (DST). The Premarket Approval (PMA) submission included...

December 20, 2022

Orthopedics and Spine

Life Spine Announces FDA 510(K) Clearance for the TruLift® Lateral Expandable Spacer System and Lateral Plate System

Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced that it has received clearance from the U.S. Food & Drug Administration (FDA) to market the TruLift Lateral Expandable...

December 16, 2022

Orthopedics and Spine

ChoiceSpine™ Announces Line Extension of their Harrier™ Stand-Alone Anterior Lumbar Interbody Fusion System

ChoiceSpine LLC, a privately-held spinal device manufacturer based in Knoxville, TN, announces the launch of an additional lordotic offering for their stand-alone anterior lumbar interbody – Harrier SA. Harrier SA is a 3D printed stand-alone screw-based system incorporating ChoiceSpine’s proprietary...

November 22, 2022

Orthopedics and Spine

CurvaFix Receives FDA Clearance for Smaller-diameter, Intramedullary Implant for Pelvic Fracture Fixation

CurvaFix, Inc., a developer of medical devices to repair fractures in curved bones, announced it has received 510(k) clearance (K222505) from the U.S. Food & Drug Administration (FDA) for its smaller-diameter CurvaFix® IM Implant indicated for fixation of fractures of...

November 1, 2022