Orthopedics and Spine

Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that it has received clearance from the U.S. Food & Drug Administration (FDA) to market the PLATEAU-A Ti Anterior Lumbar Spacer System. “With the increased usage of anterior column reconstruction, PLATEAU-A Ti fills…

FX received 510k clearances for their TiN (Titanium Nitride) Coated Humeral Heads and Glenospheres. The new addition of TiN coated humeral heads and glenospheres adds unique-to-market prostheses to the FX portfolio. The TiN coated humeral heads and glenospheres are identical to the current humeral heads and glenospheres that we offer but with the TiN coating applied. The TiN coated…

Wright Medical Group N.V. (NASDAQ: WMGI) today announced that the first shoulder arthroplasty procedure was performed using groundbreaking BLUEPRINT Mixed Reality Technology at Mayo Clinic’s campus in Rochester, Minnesota.  Joaquin Sanchez-Sotelo, M.D., Ph.D, performed the procedure utilizing BLUEPRINT OR Visualization Mixed Reality software, which provides a 3-D holographic view of the patient’s pre-operative plan. Robert Palmisano, president and chief executive…

Medtronic plc (NYSE:MDT), a global leader in medical technology, and Medicrea, a pioneer in the transformation of spinal surgery through artificial intelligence, predictive modeling and patient specific implants, today announced that they have entered into a tender offer agreement for the acquisition of all outstanding shares of Medicrea. The friendly voluntary all-cash tender offer will…

4WEB Medical, an orthopedic device company focused on developing innovative implants with an Advanced Structural Design that utilizes its proprietary Truss Implant Technology™, announced today that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Stand-Alone Anterior Lumbar Interbody Fusion Device (ASTS-SA). The new design allows fixation screws to…

GTX medical (GTX), today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its implantable Go-2 system which was designed to promote the recovery of leg motor functions and neurological control in adults with spinal cord injuries (SCI) and paralysis. The Go-2 System provides Targeted Epidural Spinal Stimulation (TESS)…

Centinel Spine, LLC, the largest privately-held spine company focused on anterior column reconstruction, today announced FDA approval for the manufacturing transfer of both the prodisc® C Cervical Total Disc Replacement and prodisc® L Lumbar Total Disc Replacement systems to new strategic vendors. The FDA approval for manufacturing transfer is a critical milestone for Centinel Spine as it allows the…

Smith+Nephew, the global medical technology business, today announces the launch of its new JOURNEY II Unicompartmental Knee (UK) System. Built on the heritage of one of the most clinically successful partial knees,1,2 and paired with proprietary OXINIUM™ Technology, JOURNEY II UK is designed to help patients rediscover their normal life. JOURNEY II UK provides a highly personalized…

Zebra Medical Vision, the deep-learning medical imaging analytics company, announces today its fifth FDA 510(k) clearance for its Vertebral Compression Fractures (VCF) product. The company’s latest AI solution automatically identifies findings suggestive of compression fractures, enabling clinicians to place patients that are at risk of osteoporosis in treatment pathways to prevent potentially life-changing fractures. The…

Carmell Therapeutics, a pioneer in the development and commercialization of innovative Plasma-based Bioactive Materials (PBMs) to accelerate bone and soft tissue healing, announced that the U.S. Food and Drug Administration (FDA) last week has granted Fast Track designation for the Company’s first product, a Bone Healing Accelerant (BHA). The Fast Track designation provides the company benefits in…