FDA OKs Opus' arthroscopic rotator cuff repair technology:
This article was originally published in Clinica
Opus Medical has launched in the US its totally arthroscopic rotator cuff repair technology, after gaining FDA 510(k) clearance for the final component of the system. The minimally invasive AutoCuff device provides surgeons with a "knot-free" method of suturing tissue to bone, which could lower procedure costs by minimising surgery time, says the San Juan Capistrano, California firm. It is also expected to reduce patient rehabilitation time. The remaining element of the product to gain approval was the reusable SmartStitch handle component.