X-Bolt

FDA 510(k) approval

X-Bolt Orthopaedics Gains FDA Clearance for Hip Nailing and Hip Plating (K181640)

15 Oct 2018

X-Bolt Orthopaedics achieved FDA 510(k) clearance to market the X-Bolt Hip Nailing and Hip Plating fixation systems.

These systems received CE Mark approval in 2011 and have been the subject of two large clinical trials, WHITE1 (100 subjects) and WHITE4 (1,140 subjects), the latter of which is the largest ever trial comparing extracapsular hip fracture fixation devices; it completed recruitment at the beginning of 2Q18.

The trial is being independently run by Oxford University’s Clinical Trials and Research Unit.

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