OrthoPediatrics earns FDA clearance for small stature scoliosis system: 4 details

OrthoPediatrics received FDA 510(k) clearance for its new Response 4.5/5.0mm small stature scoliosis system.

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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.

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