Cleared Traditional

K250894 - Eminent Spine Posterior SI System

K250894 is an FDA 510(k) clearance for Eminent Spine Posterior SI System, manufactured by Eminent Spine. The device is a Class 2 Orthopedic device with product code OUR cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K250894 · Eminent Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
196d
Days
Class 2
Risk

K250894 is an FDA 510(k) clearance for the Eminent Spine Posterior SI System. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by Eminent Spine (Plano, US). The FDA issued a Cleared decision on October 7, 2025 after a review of 196 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Eminent Spine devices

FDA 510(k) Submission Details - K250894

510(k) Number K250894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2025
Decision Date October 07, 2025
Days to Decision 196 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 122d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OUR Device Classification - Class 2, Special Controls

Product Code OUR Sacroiliac Joint Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
Definition Sacroiliac Joint Fusion
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - OUR Sacroiliac Joint Fixation

All 119
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K250894.
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K250647 · Sivantage · Jul 2025
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K250247 · Wenzel Spine, Inc. · Jul 2025
The Rialto™ SI Fusion System
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