Medicrea Gains FDA Clearance for Patient-Specific Spinal Cage

By Julie A. Vetalice

Medicrea obtained the first FDA 510(k) clearance to market patient-specific spinal cages. Using the UNiD™ artificial intelligence-driven ASI™ (Adaptive Spine Intelligence) platform, the company can now support digital planning, in-house manufacture and supply of devices from its IB3D™ line of 3D-printed titanium interbody devices.

UNiD IB3D is designed as an alternative to the surgeon testing among available sizes to select an implant that will suit the patient (but which lacks optimization).

To date, Medicrea has completed >2,400 surgeries with patient-specific implants.

In other patient-specific spine news, K2M received FDA 510(k) clearance to market BACS® Patient-Specific devices. The fifth module in the BACS platform allows for the creation of pre-contoured rods, rails and templates, and was K2M's first patient-specific indication.

Sources: Medicrea; ORTHOWORLD Inc.

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory