Medicrea gets FDA 510(k) clearances for PASS XS posterior fixation and LigaPASS XS band connector components

23 October 2016 (Last Updated October 23rd, 2016 18:30)

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 intended to address pediatric spinal deformities in small stature patients.

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 intended to address pediatric spinal deformities in small stature patients.

The firm has teamed up with leading pediatric spinal surgeons to develop low-profile implants meant to meet the demands of pediatric deformity surgery.

"The extra-small ‘XS’ extension of the PASS and LigaPASS technology will allow surgeons to effectively treat pediatric patients using around 40% less implant volume in each surgery."

The extra-small ‘XS’ extension of the PASS and LigaPASS technology will allow surgeons to effectively treat pediatric patients using around 40% less implant volume in each surgery and the lowest construct profile in-situ available on the market, whilst 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.

Medicrea Group president and CEO Denys Sournac said: “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 personalised analytical services and implant solutions for the treatment of complex spinal conditions.”

Medicrea is expected to announce the first US surgery with the PASS XS and LigaPASS XS components in early November.


Image: The PASS XS posterior fixation and LigaPASS XS band connector components. Photo: courtesy of Medicrea.