GS Medical Co., Ltd. · Class II · Cleared Dec 6, 2024
| K-number | K243073 |
| Device name | AnyPlus Navigated Instruments System |
| Applicant | GS Medical Co., Ltd. |
| Product code | OLO |
| Device class | Class II |
| Decision date | Dec 6, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 882.4560 |
The AnyPlus Navigated Instruments System consists of taps and a driver used to place poly-axial screws from the AnyPlus Spinal Fixation System during navigated thoracolumbar fusion procedures. The system works with the Medtronic StealthStation® S7 navigation system to assist surgeons in precisely locating anatomical structures in open or minimally invasive spinal surgery.
The subject device taps and driver are fabricated from UNS S45500 Precipitation-Hardened Stainless Steel per ASTM F899, with identical material and manufacturing process to the primary predicate AnyPlus Spinal Fixation System. The device has equivalent critical lengths with a +/-0.15mm tolerance difference compared to the additional predicate Navigated CD Horizon Solera instruments.
ASTM F899 for stainless steel material specification. Performance testing included recognition and location testing with the Medtronic StealthStation® navigation system, dimensional accuracy verification, and compatibility assessment.
The subject device shares identical material composition, technological characteristics, and principle of operation with the primary predicate (AnyPlus Spinal Fixation System K091717). It also has identical indications for use as the additional predicate (Navigated CD Horizon Solera K140454). Performance testing demonstrated the subject device taps and driver successfully register with and place screws via the Medtronic StealthStation system equivalently to the predicate, with critical length differences of only +/-0.15mm raising no new safety or effectiveness concerns.
View the full FDA submission: accessdata.fda.gov