| K-number | K252081 |
| Device name | SportLinc Syndesmosis Device |
| Applicant | Lincotek Medical |
| Product code | HTN |
| Device class | Class II |
| Decision date | Mar 27, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3030 |
The SportLinc Syndesmosis Device is a sterile single-use implant designed to stabilize ankle syndesmotic injuries (disruptions of the ligaments connecting the tibia and fibula). It consists of ultra-high molecular weight polyethylene (UHMWPE) suture tensioned between two low-profile titanium alloy buttons, assembled onto an inserter instrument and packaged as a sterile kit. It can be used as a standalone device or to complement plate fixation in Weber B and C ankle fractures.
The subject device has identical technological characteristics to the predicate device: the same basic design, same materials (titanium alloy buttons and UHMWPE suture), and identical principle of operation. Mechanical testing demonstrated substantially equivalent performance.
Static and dynamic fatigue testing; MR compatibility testing per FDA Guidance on Testing and Labeling Medical Devices for Safety in the MR Environment; biocompatibility testing per FDA Guidance on ISO 10993-1 (Biological evaluation of medical devices - Part 1).
View the full FDA submission: accessdata.fda.gov