Zespin SI Joint Fusion System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K223521 FDA 510(k)
- FDA Product Code
- OUR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3040 FDA 510(k)
- Regulation Number
- 888.3040 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Zespin SI Joint Fusion System is a medical device classified as an orthopedic implant designed for sacroiliac joint fusion. It provides stabilization and structural support to the sacroiliac joint, addressing conditions such as sacroiliac joint disruptions and degenerative sacroiliitis by promoting bony fusion between the sacrum and ilium.
This system is intended for use in an operating room setting by qualified surgeons during orthopedic procedures. Supplied sterile and intended for single-use, it is regulated under FDA 510(k) clearance (K223521) as a substantially equivalent device in the orthopedic category. No additional regulatory markings or MRI safety classifications are specified.
Frequently asked questions
What clinical conditions is the Zespin SI Joint Fusion System designed to address in the sacroiliac joint area?
The Zespin SI Joint Fusion System is specifically designed to address sacroiliac joint disruptions and degenerative sacroiliitis. It provides stabilization and structural support to promote bony fusion between the sacrum and ilium, helping to restore stability in patients experiencing pain or dysfunction due to these conditions.
Is the Zespin SI Joint Fusion System intended for reuse, or is it meant to be used only once?
The Zespin SI Joint Fusion System is supplied sterile and explicitly intended for single-use only. This ensures patient safety and maintains sterility during surgical procedures, as reuse is not recommended or supported by the manufacturer.
How is the Zespin SI Joint Fusion System regulated by the FDA, and what does that mean for its use?
The Zespin SI Joint Fusion System holds FDA 510(k) clearance (K223521) under the Traditional review pathway, classified as substantially equivalent to a predicate device in the orthopedic category. This means it has undergone FDA evaluation to confirm its safety and effectiveness for its intended use in sacroiliac joint fusion procedures, performed only by qualified surgeons in an operating room setting.
What type of surgical setting is required for the implantation of the Zespin SI Joint Fusion System?
The Zespin SI Joint Fusion System is designed for use exclusively in an operating room setting, where it can be implanted by qualified surgeons during orthopedic procedures. It is not intended for outpatient clinics, office-based surgeries, or non-surgical environments.
Are there any specific storage instructions or considerations for the Zespin SI Joint Fusion System before use?
While the provided data does not specify detailed storage instructions, the system is supplied sterile and intended for single-use. Standard sterile medical device storage practices should be followed—such as protecting it from contamination, extreme temperatures, and physical damage—until immediate preoperative use. Always refer to the manufacturer’s included packaging instructions for precise handling.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Zespin SI Joint Fusion System - Aegis Spine | FDA Evidence Review, ZESPIN SI Joint Fusion System (K223521) — FDA 510 (k) | Innolitics, K223521 - ZESPIN SI Joint Fusion System - Orthopedic, K210035 FDA 510(k) - ZESPIN SI Joint Fusion System | Aegis Spine, ZESPIN SI Joint Fusion System (UDI: 1024-2060) Specs & FDA Data
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K223521 | Class II | Active |
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Manufacturer
- Manufacturer
- Aegis Spine, Inc.
Sources (1)
- FDA 510(k) K223521 24 fields · synced Sep 19, 2026