FDA Clears Two Medicrea Specialized Components for Pediatric Spinal Deformity

The Medicrea Group, pioneering the development and manufacture of personalized analytical services and implant solutions for the treatment of complex spinal conditions, announced that it has received two unique 510(k) clearances from the U.S. Food and Drug Administration (FDA) for its PASS XS posterior fixation and LigaPASS XS band connector components designed to address pediatric spinal deformities in small stature patients.
 
The Company has worked with a team of leading pediatric spinal surgeons to develop low-profile implants specially tailored for the unique demands of pediatric deformity surgery. The extra-small ‘XS’ extension of the PASS and LigaPASS technology will enable surgeons to now effectively treat pediatric patients using around 40% less implant volume in each surgery and the lowest construct profile in-situ available on the market, while still offering the same technical innovations of the PASS LP and LigaPASS systems used on adults and UNiD™ Lab patient-specific, digital surgical planning and analytical services.
 
“By adapting our industry-leading PASS and LigaPASS deformity systems for the unique requirements of pediatric deformity through the ‘XS’ components, Medicrea is continuing to strengthen its position as a leader in FDA-cleared personalized analytical services and implant solutions for the treatment of complex spinal conditions,” stated Denys Sournac, President and CEO.
 
Medicrea is anticipated to announce the first U.S. surgery with the PASS XS and LigaPASS XS components in early November.