FDAnews
www.fdanews.com/articles/202708-fda-clears-conformis-knee-replacement-system
FDA clears text

FDA Clears Conformis’ Knee Replacement System

May 11, 2021

Conformis has received 510(k) clearance from the FDA for its Identity Imprint total knee replacement system.

The knee replacement system comes in both cruciate-retaining and posterior-stabilized versions. It uses predetermined implant sizes with standard and patient-specific surgical instrumentation, enabling faster delivery times and intraoperative options that are similar to standard knee systems.

The system uses a 3D best-fit algorithm to choose implants that are best suited for patients based on computed tomography scans. The implant is delivered using the company’s sterile surgery-in-box system that is designed to provide greater efficiency while cutting down on sterilization costs.

View today's stories