Medicrea Group has received two 510(k) clearances from the US Food and Drug Administration for its PASS XS posterior fixation and LigaPASS XS band connector components.
These connector components have been designed to provide solutions to paediatric spinal deformities in small stature patients.
Medicrea had joined hands with a team of leading paediatric spinal surgeons in developing the low-profile implants tailor-made for the special needs of paediatric deformity surgery.
The technology in PASS and LingaPASS can help surgeons in effectively treating paediatric patients using 40% less implant volume in each surgery.
It also offers the same technical innovations of PASS LP and LigaPASS systems used in adults and UNiD Lab patient-specific, digital surgical planning and analytical services.
Medicrea 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 personalized analytical services and implant solutions for the treatment of complex spinal conditions.”
Medicrea is a medical technology company that specialises in design, manufacture and distribution of spinal surgery solutions. The company operates in a $10bn market and it has a workforce of 150 people.
The company’s focus is mainly on developing market-disrupting technologies which include UNiD Technology Platform of Patient-Specific Implants and Analytical Services. Medicrea received its first FDA clearance in November 2014 for personalised spinal treatment modality.