X-Bolt Orthopaedics’ X-Bolt hip fracture device received FDA 510(k) approval in the fourth quarter of 2018.
Four things to know:
1. The X-Bolt device is designed to reduce reoperation rates. The implant features wings that expand in situ to offer a rotationally stronger and more secure femoral bone anchorage than traditional screw fixation.
2. The 1,000th patient completed one-year of follow-up in the World Hip Trauma Evaluation 4 trial, in which hip fracture patients were randomized to receive either a gold standard sliding hip screw device or X-Bolt at 10 U.K. centers.
3. A 100-patient randomized pilot study published in 2016, known as WHITE1, demonstrated a zero percent reoperation rate with the X-Bolt device compared to a 6 percent reoperation rate with the traditional sliding hip screw in unstable intertrochanteric hip fractures.
4. X-Bolt Orthopaedics is an Irish medical device company focused on developing hip nailing and plating solutions for hip fractures that require fixation.