Cleared Special

SI-Cure Sacroiliac Joint Fusion System (K223819) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K223819 · Alevio, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2023
Decision
28d
Days
Class 2
Risk

K223819 is an FDA 510(k) clearance for the SI-Cure Sacroiliac Joint Fusion System. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by Alevio, LLC (Birmingham, US). The FDA issued a Cleared decision on January 18, 2023 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Alevio, LLC devices

Submission Details

510(k) Number K223819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2022
Decision Date January 18, 2023
Days to Decision 28 days
Submission Type Special
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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 Technologies
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 99
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K223819.
SiJoin®T3
K213815 · Vgi Medical, Inc. · Mar 2023
Entasis 3D Dual-Lead Sacroiliac Implant System
K223708 · Corelink, LLC · Mar 2023
ZESPIN SI Joint Fusion System
K223521 · Aegis Spine, Inc. · Jan 2023
iFuse Bedrock Granite® Implant System
K222774 · SI-BONE, Inc. · Dec 2022
CASSATT™ SIJ Fixation System
K211785 · Ctl Medical Corporation · Oct 2022
UNITY Sacroiliac Joint Fixation System
K222448 · Dio Medical Corporation · Oct 2022