OrthoPediatrics received FDA 510(k) clearance for its new Response 4.5/5.0mm small stature scoliosis system.
Here are four things to know:
1. The surgical system is designed to treat pediatric patients of smaller stature who have complex scoliosis.
2. To improve fixation and reduce potential cross threading, the system features a proprietary set screw thread design.
3. Designed as a two-in-one rod reducer and de-rotator, the system features a rod-reducer instrument with versatile reduction and de-rotation capabilities that can easily snap on or off.
4. The Response 4.5/5.0mm System is OrthoPediatrics' 26th surgical system, and it is expected to launch in the fourth quarter of 2018.