Conformis Hits Regulatory Milestone in Agreement with Stryker

By Julie A. Vetalice

Conformis Hits Regulatory Milestone in Agreement with Stryker

Conformis received FDA 510(k) clearance for patient-specific instrumentation (PSI) developed under a license agreement and development agreement with Stryker Orthopaedics. With clearance of this system, which is designed for use with Stryker’s Triathlon® Total Knee (shown above), Conformis achieved the third of three milestones under the agreements and will receive $11 million from Stryker.

Conformis will now focus on its long-term distribution agreement to manufacture and supply PSI to Stryker.

“With the recent FDA clearance, we are pleased to have attained the last milestone of our project and to report the successful conclusion of our joint development agreement with Stryker,” said Mark Augusti, President and Chief Executive Officer. “Despite the global challenges of the last 12 months, the dedication of our project and support teams has enabled us to achieve this major milestone on schedule."

 

Product Labels: Knee Replacement

Tags: 510(k) Clearance, Regulatory