X-Bolt hip fracture device receives FDA approval: 4 insights

X-Bolt Orthopaedics’ X-Bolt hip fracture device received FDA 510(k) approval in the fourth quarter of 2018.

Advertisement

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. 

More articles on devices:
5 things to know about the global XLIF surgery market & top competitors
Assure partners with 2 Louisiana spine surgeons
Spinal implants, surgical devices market to reach $18B by 2024 — 15 top companies

At the Becker's 23rd Annual Spine, Orthopedic and Pain Management-Driven ASC + The Future of Spine Conference, taking place June 11-13 in Chicago, spine surgeons, orthopedic leaders and ASC executives will come together to explore minimally invasive techniques, ASC growth strategies and innovations shaping the future of outpatient spine care. Apply for complimentary registration now.

Advertisement

Next Up in Spinal Tech

Advertisement

Comments are closed.