Tenon Medical · Class II · Cleared Mar 21, 2025
| K-number | K250403 |
| Device name | Catamaran SI Joint Fusion System |
| Applicant | Tenon Medical |
| Product code | OUR |
| Device class | Class II |
| Decision date | Mar 21, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3040 |
The CATAMARAN SI Joint Fusion System is a sacroiliac joint fixation device intended for sacroiliac joint fusion in patients with sacroiliac joint disruptions, degenerative sacroiliitis, or those requiring sacropelvic fixation as part of lumbar or thoracolumbar fusion. The system consists of titanium alloy implants (Ti6A1-4V ELI per ASTM F136) in various sizes along with reusable and single-use surgical instruments designed for placement via an inferior-posterior surgical approach.
The Catamaran system has the same technological characteristics and principles of operation as the predicate devices. It utilizes titanium alloy implants that allow autologous bone graft material placement within the implant barrels to support SI joint fixation and fusion, provided with associated Class II surgical instruments for implant delivery.
ASTM F136 is cited as the material standard for the Ti6A1-4V ELI titanium alloy used in the implants. No other specific test methods or consensus standards are detailed in this summary document.
Substantial equivalence is based solely on a modification of indications for use, not device design or function. The Catamaran system shares identical technological characteristics and operating principles with the predicate Catamaran Sacroiliac Joint Fixation System (K231944, K180818). The expanded indications (adding sacropelvic fixation augmentation) do not introduce new safety or effectiveness questions because the device's fundamental design, materials, and mechanism of action remain unchanged from the already-cleared predicate.
View the full FDA submission: accessdata.fda.gov