Amplitude Surgical Files for ANATOMIC Knee 510(k)

By Julie A. Vetalice

Amplitude Surgical filed for FDA 510(k) clearance of its posterior stabilized ANATOMIC® knee prosthesis.

This would be the fourth geographic regulatory milestone for the product, which is presently registered in the EU (1Q13), Australia (3Q15) and more recently in South Africa. The device has been used in >17,000 surgeries since launch.

Click here for other companies that carry posterior stabilized knee designs.

Sources: Amplitude Surgical; ORTHOWORLD Inc.

Product Labels: Knee Replacement

Tags: 510(k) Clearance, Regulatory