SurGenTec, LLC · Class II · Cleared Mar 20, 2026
| K-number | K253604 |
| Device name | TiLink-L Navigation Instruments |
| Applicant | SurGenTec, LLC |
| Product code | OLO |
| Device class | Class II |
| Decision date | Mar 20, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 882.4560 |
The TiLink-L Navigation Instruments are surgical tools (drill bit, drill guide, and inserter) designed for use with the TiLink-L Joint Fusion System to assist surgeons in precisely locating anatomical structures during sacroiliac joint fusion surgery. They work with the Medtronic StealthStation System S8 navigation platform to enable accurate implant placement in open or minimally invasive procedures.
The TiLink-L Navigation Instruments have identical intended use, fundamental scientific technology, and material composition as the primary predicate device (Medtronic Navigated Manual Reusable Instruments K161210). Both are manufactured from stainless steel per ASTM F899 and function as manual reusable navigated surgical instruments.
ASTM F2554 (positional accuracy), ASTM F3208 (cleaning), ASTM F899 (stainless steel), ISO 17664 (sterilization), ISO 11137 (sterilization validation), ISO 11607 (packaging and shelf-life), and ISO 10993-1 (biocompatibility).
The TiLink-L Navigation Instruments are substantially equivalent because they share the same intended use, fundamental scientific technology, and material as the predicate device. All non-clinical performance testing met predetermined acceptance criteria, demonstrating the device performs as intended and is as safe and effective as the legally marketed predicate.
View the full FDA submission: accessdata.fda.gov