Medacta Gains FDA Clearance for Multiple Sports Medicine Products

By Julie A. Vetalice

Medacta Gains FDA Clearance for Multiple Sports Medicine Products

Medacta was granted FDA 510(k) clearace for three new sports medicine products: MectaLock All-Suture Anchor, MectaTap TI Suture Anchor and Mectafix CL Fixation Button with Continuous Loop. These three products for arthroscopy are now being introduced in the U.S. market.

MectaLock All-Suture Anchors are indicated for the repair of the labrum of the hip and shoulder, as well as rotator cuff and biceps tendon repair. MectaTap TI Suture Anchors are indicated for rotator cuff and biceps tenodesis repair. The MectaFix CL Fixation Button with Continuous Loop is indicated for use in reconstructive treatment and extra-cortical femoral fixation during anterior cruciate ligament reconstruction. The product design eliminates the number of sutures needed by combining the pulling and flipping suture.

Earlier this year, the company received CE Mark Approval for a number of their sports medicine devices and announced first procedures.

Product Labels: Traditional Soft Tissue Repair

Tags: 510(k) Clearance, Regulatory