Category: ORTHOPEDICS - Page 2 - Start Medical Product Development

Hyalex Orthopaedics Announces FDA 510(k) Clearance of the HYALEX Slalom™ MTP Hemiarthroplasty System

April 21, 2026

LEXINGTON, Mass., April 21, 2026 (GLOBE NEWSWIRE) — Hyalex Orthopaedics today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its HYALEX Slalom™ MTP Hemiarthroplasty Implant, a next-generation implant designed around the proprietary Hydrosurf™ materials platform, for the treatment of degenerative conditions affecting the first metatarsophalangeal (MTP) joint, including hallux rigidus.

Phantom Neuro secures approval for muscle-machine interface trial

April 16, 2026

The CYBORG study aims to assess the efficacy, safety and usability of the system.

Zimmer Biomet wins expanded FDA nod for shoulder systems

April 16, 2026

Zimmer Biomet (NYSE:ZBH) announced that it received FDA 510(k) clearance for a line extension to its existing Identity and Comprehensive shoulder system

Miracell Receives FDA 510(k) Clearance for SMART M-CELL PRP Concentration System and SMART M-CELL Bone Marrow Concentration System

April 10, 2026

Blood- and bone marrow-based efficient growth factors extraction system demonstrates substantial equivalence and high cell viability

MedCAD’s AccuStride® Receives FDA 510(k) Clearance for New Anatomical Lower Leg Region Tib/Fib Solution

April 8, 2026

DALLAS, April 8, 2026 /PRNewswire/ — Dallas-based MedCAD has received FDA 510(k) clearance of its AccuStride® lower leg tibia and fibula system, making these patient-specific precision devices available to surgeons. The unique design of the custom-made planning and surgical guides will enable orthopedic surgeons to correct multiple related pathologies and osteotomies in a single procedure.

FDA grants 510(k) clearance for Allevion Medical’s Vantage system

April 6, 2026

Vantage’s intuitive three-step workflow, locate, dilate, decompress, enables physicians to perform procedures with consistency.

Spinal cord stimulator stays rigid for surgery, then softens inside the body

April 5, 2026

What if chronic diseases, which are difficult to treat with medicine alone, could be managed with electricity? As “neuromodulation”—a technology that restores bodily balance by sending signals directly to nerves—gains attention, a Korean research team has brought this possibility one step closer to reality.

Research moves closer to ‘smart’ sensors in knee replacements

April 3, 2026

If you have a knee replacement, imagine pointing your phone at your knee and pulling up an app that tells you how much stress the artificial joint is experiencing. Knowing the activities that cause the biggest problems—which can lead to a second replacement surgery—would be invaluable. Research led by Binghamton University is closer to making this technology a reality.

Smart titanium implant enables rapid bacteria elimination and enhanced bone regeneration

April 1, 2026

A research team from the Department of Orthopedics and Traumatology, School of Clinical Medicine, LKS Faculty of Medicine at the University of Hong Kong (HKUMed), has developed a titanium implant surface that can be activated by near-infrared (NIR). With just 15 minutes of NIR irradiation, this surface can eliminate 99.94% of Staphylococcus aureus (S. aureus) biofilms without the use of antibiotics, while simultaneously promoting bone-implant fusion.

Genesys Spine Announces Launch of the SIros-X™ System for Sacroiliac Joint Fusion and Pelvic Fixation of Pedicle Screw Constructs

March 31, 2026

AUSTIN, Texas, March 31, 2026 /PRNewswire/ — Genesys Spine today announced the successful completion of the first surgical procedure utilizing the SIros-X System, a next-generation solution designed to deliver precision, adaptability, and control for complex sacroiliac joint fusion and pelvic fixation. The inaugural case was performed by Scott L. Parker, M.D., at Ascension Saint Thomas Hospital Midtown, Nashville, TN, marking an important milestone as the system begins clinical use.

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