Cleared Traditional

ZESPIN SI Joint Fusion System (K223521) - FDA 510(k) Clearance

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

K223521 · Aegis Spine, Inc. · Orthopedic device
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Jan 2023
Decision
58d
Days
Class 2
Risk

K223521 is an FDA 510(k) clearance for the ZESPIN SI Joint Fusion System. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by Aegis Spine, Inc. (Englewood, US). The FDA issued a Cleared decision on January 20, 2023 after a review of 58 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Aegis Spine, Inc. devices

Submission Details

510(k) Number K223521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2022
Decision Date January 20, 2023
Days to Decision 58 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 122d · This submission: 58d
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 Peers - OUR Sacroiliac Joint Fixation

All 99
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K223521.
T-FIX™ 3DSI Joint Fusion System
K230689 · Cutting Edge Spine, LLC · Apr 2023
SiJoin®T3
K213815 · Vgi Medical, Inc. · Mar 2023
Entasis 3D Dual-Lead Sacroiliac Implant System
K223708 · Corelink, LLC · Mar 2023
SI-Cure Sacroiliac Joint Fusion System
K223819 · Alevio, LLC · Jan 2023
iFuse Bedrock Granite® Implant System
K222774 · SI-BONE, Inc. · Dec 2022
CASSATT™ SIJ Fixation System
K211785 · Ctl Medical Corporation · Oct 2022