Cleared Traditional

panaSIa SI Fusion System

K250247 · Wenzel Spine, Inc. · Orthopedic
Jul 2025
Decision
163d
Days
Class 2
Risk

About This 510(k) Submission

K250247 is an FDA 510(k) clearance for the panaSIa SI Fusion System, a Sacroiliac Joint Fixation (Class II — Special Controls, product code OUR), submitted by Wenzel Spine, Inc. (Austin, US). The FDA issued a Cleared decision on July 9, 2025, 163 days after receiving the submission on January 27, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K250247 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 2025
Decision Date July 09, 2025
Days to Decision 163 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code OUR — Sacroiliac Joint Fixation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040
Definition Sacroiliac Joint Fusion