US FDA clears Medicrea’s paediatric Pass XS and LigaPass XS components

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Medicrea UNiD planning software (Surgimap)
Medicrea UNiD planning software (Surgimap)

The Medicrea Group has received two 510(k) clearances from the US Food and Drug Administration (FDA) for its Pass XS posterior fixation and LigaPass XS band connector components, designed to address paediatric spinal deformities in small stature patients.

The company has worked with a team of paediatric spinal surgeons to develop low-profile implants specially tailored for the demands of paediatric deformity surgery. The extra-small ‘XS’ extension of the Pass and LigaPass technology are intended to enable surgeons to effectively treat paediatric patients using around 40% less implant volume in each surgery and the lowest construct profile in-situ available on the market, while still offering UNiD Lab patient-specific, digital surgical planning and analytical services.

Medicrea is expected to announce the first US surgery with the Pass XS and LigaPass XS components in early November 2016.