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Reimbursement / Regulatory

Conformis Gains FDA Clearance for Next-Gen Hip -

Conformis received FDA 510(k) clearance of a next-generation Conformis Hip System. Since limited launch in mid-2018, the device has been used in over 400 surgeries; the new system incorporates design improvements based on surgeon feedback. The Conformis Hip uses proprietary imaging and design software to create a patient-specific pre-operative surgical plan for use with iJig instruments and patient-matched implants. The instruments work with anatomic landmarks to help place and orient the femoral stem and acetabular cup. A proprietary single-use reamer enables patient-matched reaming.