Cleared Traditional

K213590 - Blue Topaz Sacroiliac Screw System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K213590 · Osseus Fusion Systems, LLC · Orthopedic device
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Mar 2022
Decision
109d
Days
Class 2
Risk

K213590 is an FDA 510(k) clearance for the Blue Topaz Sacroiliac Screw System. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by Osseus Fusion Systems, LLC (Dallas, US). The FDA issued a Cleared decision on March 1, 2022 after a review of 109 days - within the typical 510(k) review window.

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 Osseus Fusion Systems, LLC devices

Submission Details

510(k) Number K213590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2021
Decision Date March 01, 2022
Days to Decision 109 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
13d faster than avg
Panel avg: 122d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Empirical Testing Corp
Nathan Wright

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OUR Sacroiliac Joint Fixation

All 130
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