FDA 510(K) Clearances ...

Elizabeth Engler Modic, Editorial Director - Manufacturing Group

Published September 30, 2019
Developed by faculty at Case Western Reserve University School of Medicine and physicians from University Hospitals of Cleveland, EsoCheck, a swallowable balloon device used to collect cells for detection of Barrett’s esophagus (BE), can now be used in clinical settings. The 5-minute outpatient test is more than 90% sensitive for detecting individuals with BE.

PHOTO COURTESY OF Case Western Reserve University School of Medicine
Cutting Edge Spine sacral-iliac (SI) joint fusion system, EVOL-SI, is available to the market. It features surface modification to improve osseointegration through optimized hydrophilicity and surface chemistry, mediating bioactivity and influencing tissue regeneration to yield early bone formation, improved mechanical stability, with faster fusion and stronger fixation.

4WEB Medical can begin marketing its Cervical Spine Truss System-Stand Alone (CSTS-SA) interbody fusion device. It has an open architecture, Advanced Structural Design that incorporates the company’s Truss Implant Technology to simulate cellular activity at the surgical site. 4WEB Medical’s manufacturing process creates a hierarchical surface roughness with features that span from the macro to nano scale. In-vitro testing has shown that stem cells attached to 4WEB’s titanium implant surface exhibited increased gene expression of certain osteogenic markers when compared to smooth titanium and PEEK.

OrthoPediatrics Corp.’s pediatric-specific system to treat fractures and deformities of the foot and ankle, PediFoot Deformity Correction System, is the company’s first system to incorporate the StarLoc variable angle locking technology, featuring a star-shaped design to offer five points of fixation. Consisting of implants and instrumentation to increase procedure throughput, PediFoot features the thinnest plates in its portfolio. 


PHOTO COURTESY OF 4WEB MEDICAL
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