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Juliet Ti

FDA 510(k)

Class II (US FDA 510(k))

510(k) K181203

by Spineart

Identifiers

510(k) Number
K181203 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 Juliet Ti is a titanium interbody cage that incorporates Spineart's Ti‑LIFE Technology, a porous, interconnected structure designed to mimic trabecular bone and support cell colonisation. The cage is intended for lateral placement in the spine to maintain disc height and promote fusion while allowing clear imaging of the implant.

The device is cleared in the United States via a special FDA 510(k) submission (K181203) and is classified under product code MAX. It is supplied as a single‑use implant, compatible with the ROMEO®2 system, and is manufactured in Switzerland. The clearance indicates substantial equivalence to a predicate device and reflects review by the Orthopedic advisory committee.

Frequently asked questions

What is the Juliet Ti used for?

The Juliet Ti is a titanium interbody cage designed for lateral placement in the spine. It is used to maintain disc height and promote fusion while supporting cell colonisation through its porous Ti‑LIFE Technology, which mimics trabecular bone.

How is the Juliet Ti supplied?

The Juliet Ti is supplied as a single‑use implant. It is manufactured in Switzerland by Spineart and is compatible with the ROMEO®2 system for surgical delivery.

Is the Juliet Ti sterile?

The device data does not explicitly state the sterility of the Juliet Ti. However, as a single‑use surgical implant, it is typically supplied sterile for direct clinical use.

What sizes or models are available?

The provided device data does not list specific sizes or models for the Juliet Ti. It is described as a single‑use implant with a porous titanium structure, but dimensional variants are not detailed in the available information.

How should the Juliet Ti be stored?

The device data does not specify storage conditions for the Juliet Ti. As a sterile, single‑use surgical implant, it should be stored in a dry, clean environment prior to use, following standard medical device handling protocols.

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: JULIET®Ti LL - Spineart, JULIET®Ti TL - SPINEMarketGroup, PDF JULIET T i PO/OL - neurospineproductreview.com, PDF JULIET T i TL - neurospineproductreview.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Spineart

Sources (1)

  • FDA 510(k) K181203 24 fields · synced Sep 21, 2026