iGPS Navigation Instruments
FDA 510(k) K251780 · SI-BONE, Inc.
510(k) numberK251780
Submission
- Device name
- iGPS Navigation Instruments
- Applicant
- SI-BONE, Inc.
Santa Clara, CA, US - Received
- June 10, 2025
- Decision date
- September 15, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OLO – Orthopedic Stereotaxic Instrument
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4560
- Specialty
- Neurology
Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.
Other 510(k)s with product code OLO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262506 | Remex Spine Surgery Navigation - Universal InstrumentsOLO · Special | Remex Medical Corp. | 08/20/2026SE |
| K261410 | Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration…OLO · Traditional | Suite 201, National Innovation Centre | 07/30/2026SE |
| K261205 | SPINEART Navigation Instrument SystemOLO · Traditional | Spineart SA | 07/29/2026SE |
| K262121 | Ion-L Navigated InstrumentsOLO · Special | SurGenTec, LLC | 07/24/2026SE |
| K261024 | TMINI Miniature Robotic SystemOLO · Traditional | THINK Surgical, Inc. | 07/24/2026SE |
| K261113 | Op.n Spine Navigation and Robotic GuidanceOLO · Traditional | Ecential Robotics | 07/22/2026SE |
| K261852 | OTS HipOLO · Special | Ortoma AB | 07/01/2026SE |
| K253921 | VERTICALE® Navigation InstrumentsOLO · Traditional | Silony Medical GmbH | 06/26/2026SE |
| K260480 | VELYS Robotic-Assisted SolutionOLO · Traditional | Depuy Ireland UC | 06/25/2026SE |
| K260369 | Dynamis Robotic Surgical SystemOLO · Traditional | LEM Surgical AG | 06/20/2026SE |
More from LEM Surgical AG
| 510(k) | Device | Decision |
|---|---|---|
| K253488 | iFuse INTRA Ti Implant SystemOUR · Traditional | 02/11/2026SE |
| K253094 | iFuse Bedrock Granite Implant SystemOUR · Special | 10/09/2025SE |
| K241504 | iFuse TORQ TNT Implant SystemOUR · Traditional | 08/19/2024SE |
| K241574 | iFuse TORQ® Implant SystemOUR · Special | 07/02/2024SE |
| K232800 | Navigation Tracking InstrumentsOLO · Traditional | 02/23/2024SE |
| K233508 | iFuse Bedrock Granite® Implant SystemOUR · Traditional | 01/26/2024SE |
| K231689 | iFuse TORQ® Implant SystemOUR · Special | 06/30/2023SE |
| K222774 | iFuse Bedrock Granite® Implant SystemOUR · Traditional | 12/22/2022SE |
| K222605 | iFuse TORQ® Implant SystemOUR · Special | 09/29/2022SE |
| K213667 | iFuse-TORQ® Implant SystemOUR · Traditional | 06/10/2022SE |
Questions and answers
When was iGPS Navigation Instruments cleared by the FDA?
iGPS Navigation Instruments (K251780) received a 510(k) decision of Substantially Equivalent on September 15, 2025, 97 days after the submission was received.
What is the product code of K251780?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.