| K-number | K242091 |
| Device name | Bolo Button System |
| Applicant | Fusion Orthopedics |
| Product code | HTN |
| Device class | Class II |
| Decision date | Dec 23, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 888.3030 |
The Bolo Button System is a surgical device consisting of two titanium alloy buttons connected by ultra-high molecular weight polyethylene suture tape. It is intended to provide fixation as an adjunct to fracture repair hardware during healing following ankle syndesmotic injuries with fracture.
The device uses titanium alloy (Ti6Al4V ELI per ASTM F136) buttons compatible with similar-sized predicate buttons, with comparable widths, thickness, lengths, and designs. The suture tape (UHMWPE per ASTM F2848) that binds both buttons is identical to that used in predicate devices. The system includes two lateral button sizes for 1.5mm and 2.0mm suture tape, sharing a common medial button.
ASTM F136 (titanium alloy), ASTM F899 (stainless steel), and ASTM F2848 (ultra-high molecular weight polyethylene suture). Validations included cleaning, packaging, and sterilization processes, along with static and dynamic engineering testing.
The Bolo Button System is substantially equivalent because it shares identical materials (titanium alloy buttons and UHMWPE suture tape), similar dimensional and geometric characteristics, and the same intended use (ankle syndesmosis fixation) as the predicate INVISIKNOT device. Non-clinical testing demonstrated equivalent performance through static and dynamic testing, and no new technological features or functional differences exist that would distinguish it from existing predicates.
View the full FDA submission: accessdata.fda.gov