K2M received FDA 510(k) clearance and a CE Mark for its Cayman United Plate System after completion of its first surgical cases.
Here are three things to know:
1. Cayman United is designed for rigid fixation to K2M's Cascadia Lateral 3D Interbody System, which features Lamellar 3D Titanium Technology. It is he only 3D-printed cage with modular fixation capabilities.
2. Cayman United's single level, one- and two-hole plate configurations match all Cascadia Lateral 3D height and lordosis options, allowing surgeons to customize the construct using a lateral approach. Single-level plate sizes are designed to minimize retraction required for placement. An assembly alignment feature keys into the Cascadia implants to resist rotation.
3. K2M's Lamellar 3D Titanium Technology uses a 3D-printing method to produce the Cascadia implants from a titanium powder. The company uses a high-energy laser beam to incorporate a rough surface architecture to stimulate bone growth.
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