Medicrea Gains FDA Clearance of TULIP GENESIS Top loading Screw

By Julie A. Vetalice

Medicrea received FDA clearance to market the TULIP GENESIS™ top loading screw, completing its UNiD™ ASI surgical planning technology.

TULIP GENESIS offers solutions for both degen and complex deformity cases, and is the only FDA-cleared system of its kind that can be used with the UNiD™ patient-specific pre-bent rod.

The implant database integrated within UNiD™ HUB software now includes 3D-printed, patient-specific IB3D™ interbody cages; UNiD™ ROD; the PASS LP™ modular screw system and TULIP GENESIS.

Denys Sournac, President and CEO, remarked, “To date, we have performed more than 4,000 cases using the UNiD ASI technology, with a strong and continuous adoption rate in the U.S. of +47% since the beginning of the year."

Source: Medicrea

Tags: 510(k) Clearance, Regulatory