Tenon Medical · Class II · Cleared Apr 8, 2026
| K-number | K260477 |
| Device name | CATAMARAN SI Joint Fusion System |
| Applicant | Tenon Medical |
| Product code | OUR |
| Device class | Class II |
| Decision date | Apr 8, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3040 |
The CATAMARAN SI Joint Fusion System is a minimally invasive surgical device intended for sacroiliac joint fusion to treat sacroiliac joint disruptions, degenerative sacroiliitis, and to stabilize the sacroiliac joint in patients undergoing lumbar or thoracolumbar fusion. The system consists of titanium alloy implants (available in various widths and lengths) that accept autologous bone graft material, along with reusable and single-use surgical instruments for inferior-posterior implant placement.
The device has the same technological characteristics and principles of operation as the predicate devices (CATAMARAN SI Joint Fusion System models K250403, K231944, and K180818). Modifications were made to the instruments, but these do not raise new safety or effectiveness questions.
Biocompatibility Assessment per ISO 10993, Sterilization Validation per ISO 17664, and ISO 13485 requirements for design controls, nonconforming product handling, corrective action, and preventative action.
The CATAMARAN SI Joint Fusion System is substantially equivalent to the cited predicate devices because it maintains the same technological characteristics, principles of operation, and intended use, with instrument modifications that do not introduce new safety or effectiveness concerns.
View the full FDA submission: accessdata.fda.gov