MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D …
FDA 510(k)Class II (US FDA 510(k))
by Mirus Llc
Identifiers
- 510(k) Number
- K191906 FDA 510(k)
- FDA Product Code
- MAX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3080 FDA 510(k)
- Regulation Number
- 888.3080 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The MiRus 3D Printed Lumbar Interbody Fusion Systems are interbody fusion devices designed for spinal stabilization. These systems include four variants—Callisto for Posterior Lumbar Interbody Fusion (PLIF), HYPERION for Transforaminal Lumbar Interbody Fusion (TLIF), CALYPSO for Lateral Lumbar Interbody Fusion (LLIF), and ANTARES for Anterior Lumbar Interbody Fusion (ALIF)—each featuring a 3D printed titanium lattice structure. The devices are intended for use in skeletally mature patients undergoing lumbar spine fusion procedures at contiguous levels from L1-L2 to L5-S1. Their design aims to enhance bone ingrowth and structural integration within the lumbar spine.
The systems are supplied as sterile, single-use devices and are regulated under FDA 510(k) clearance (K191906) as substantially equivalent to existing spinal fusion products. Each variant is tailored for specific surgical approaches, with precise anatomical sizing to accommodate lumbar interbody fusion requirements. Storage and handling follow standard sterile medical device protocols. The devices are classified as Class II under FDA regulations, adhering to orthopedic device standards for spinal stabilization.
Frequently asked questions
What are the MiRus 3D Printed Lumbar Interbody Fusion Systems used for?
These systems are designed for lumbar spine fusion in skeletally mature patients, addressing degenerative conditions or instability at contiguous levels from L1-L2 to L5-S1. Each variant—Callisto (PLIF), HYPERION (TLIF), CALYPSO (LLIF), and ANTARES (ALIF)—is tailored to specific surgical approaches, providing precise anatomical sizing and a 3D printed titanium lattice structure to promote bone ingrowth and structural integration.
How are the MiRus 3D Printed Lumbar Interbody Fusion Systems supplied and sterilized?
The devices are supplied as sterile, single-use implants. Sterility is maintained through validated manufacturing processes, ensuring no reuse. Standard sterile medical device handling protocols apply, including proper storage to preserve integrity until surgical use.
Are these devices reusable or intended for single use?
These systems are explicitly designed for single-use only. The 3D printed titanium lattice structure and sterile packaging are optimized for one-time surgical application, preventing contamination risks associated with reuse. Single-use aligns with FDA Class II orthopedic device standards for spinal stabilization.
What regulatory clearance do the MiRus 3D Printed Lumbar Interbody Fusion Systems hold?
The systems hold FDA 510(k) clearance under K191906, classified as substantially equivalent to existing spinal fusion products. This clearance confirms compliance with FDA Class II orthopedic device standards for spinal stabilization, ensuring safety and performance for lumbar interbody fusion procedures.
How should these devices be stored before use?
Storage follows standard sterile medical device protocols to maintain integrity. Devices should be kept in their original, sealed packaging until immediately before use, protected from moisture, heat, and physical damage. Proper storage ensures sterility and functionality, adhering to manufacturer guidelines for 3D printed titanium implants.
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: 3DR Lumbar Interbody System - MiRus, MiRus® Announces First Clinical Use of the MiRus® 3DR™ Printed Lumbar ..., MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191906 | Class II | Active |
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Manufacturer
- Manufacturer
- Mirus Llc
- FDA Applicant
- MiRus, LLC
Sources (1)
- FDA 510(k) K191906 24 fields · synced Oct 1, 2026