| K-number | K242806 |
| Device name | Medyssey Navigation System |
| Applicant | Medyssey Co, Ltd. |
| Product code | OLO |
| Device class | Class II |
| Decision date | Apr 16, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 882.4560 |
The Medyssey Navigation System is a set of reusable surgical instruments (bone taps and screw drivers) made of medical-grade stainless steel. It works with the Medtronic StealthStation Navigation System to help surgeons precisely locate anatomical structures during spinal surgery for placement of pedicle screw implants in open, minimally invasive, or percutaneous procedures.
The Medyssey Navigation System instruments have similar design, dimensions, materials, and technology to the predicate Medtronic navigated instruments. Both are intended for use with the Medtronic StealthStation System and NavLock tracker arrays to assist in anatomical localization during spinal procedures.
Comparative dimensional analysis; reprocessing validation per ANSI/AAMI ST98 and ISO 17665; biocompatibility data leveraged from predicate devices K181978 and K232218.
The Medyssey Navigation System instruments function identically to the predicate navigated screwdrivers and taps—both work with the same Medtronic StealthStation platform to guide surgical placement. Performance testing showed comparable dimensional accuracy and compatibility. Since they share the same intended use, technological characteristics, materials, and demonstrated functionality with no new safety or effectiveness concerns, substantial equivalence is established.
View the full FDA submission: accessdata.fda.gov