Foundation Surgical Group, Inc. · Class II · Cleared Apr 16, 2026
| K-number | K260011 |
| Device name | Foundation Surgical Navigated Lateral Disc Prep Instruments |
| Applicant | Foundation Surgical Group, Inc. |
| Product code | OLO |
| Device class | Class II |
| Decision date | Apr 16, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 882.4560 |
The Foundation Surgical Navigated Lateral Disc Prep Instruments are orthopedic stereotaxic instruments designed to assist surgeons in precisely locating anatomical structures during spinal disc preparation procedures. The instruments are compatible with the Medtronic StealthStation S8 navigation system and include trials, dilators, awls, taps, shavers, cobbs, and osteotomes manufactured from medical-grade stainless steel for preparing the intervertebral disc space prior to lateral interbody fusion implant placement.
The subject and predicate devices have nearly identical technological characteristics including device design and critical geometry, indications for use, materials of manufacture (medical grade stainless steel per ASTM F899), and principles of operation and function. Both are compatible with Medtronic NavLock Trackers and the StealthStation S8 system for computer-assisted navigation during spinal surgery.
ASTM F899 standard for medical-grade stainless steel material specification. ISO 13485 requirements cited for design controls, nonconforming product management, corrective and preventative actions.
View the full FDA submission: accessdata.fda.gov