FDA Clearances of Specialized Components for Medicrea Pediatric Deformity

By Julie A. Vetalice

Medicrea received FDA 510(k) clearances for its PASS® XS posterior fixation and LigaPASS® XS band connector components, designed to address pediatric spinal deformities in small stature patients.

The extra-small XS extensions of PASS and LigaPASS technology will allow surgeons to treat pediatric patients using ~40% less implant volume in each surgery. Like the adult-sized implants, these versions can be used with UNiD™ Lab patient-specific digital surgical planning and analytical services.

First U.S. surgery with PASS XS and LigaPASS XS are expected in mid-4Q16.

Source: Medicrea

Tags: 510(k) Clearance, Regulatory