Tenon Medical (TNON) said Thursday that its Catamaran SI Joint Fusion System received 510(k) clearance from the US Food and Drug Administration.
The company said that the updated clearance for the SI Joint Fusion System, which offers a minimally invasive surgical approach to the sacroiliac joint, incorporates instrument upgrades and reclassifies certain instruments from disposable to reusable status.
Tenon said that these updates will further improve the system's performance and provide economic benefits by eliminating ongoing per-procedure costs previously associated with disposable instrumentation.
Shares of the company were up 8% in Thursday's premarket trading.