Cleared Traditional

iGPS Navigation Instruments

K251780 · SI-BONE, Inc. · Orthopedic

Sep 2025

Decision

97d

Days

Class 2

Risk

About This 510(k) Submission

K251780 is an FDA 510(k) clearance for the iGPS Navigation Instruments, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by SI-BONE, Inc. (Santa Clara, US). The FDA issued a Cleared decision on September 15, 2025, 97 days after receiving the submission on June 10, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K251780 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 10, 2025
Decision Date	September 15, 2025
Days to Decision	97 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OLO — Orthopedic Stereotaxic Instrument
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.4560
Definition	Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.