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TxTi IBF System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K183064

by Innovasis, Inc.

Identifiers

510(k) Number
K183064 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 TxTi IBF System is a titanium interbody fusion device with up to 66% porosity and integrated with HAnano Surface technology. It is designed for enhanced fusion capabilities while maintaining biocompatible features inherent to titanium implants. The device features a Tetracell structure and is intended for orthopedic applications.

The TxTi IBF System is supplied as a single-use device and has been cleared through the FDA Traditional 510(k) pathway with K183064. It has been shown to be substantially equivalent to predicate devices K180078 and K162496. The device is manufactured by Innovasis, Inc. and is classified as a Class 2 Orthopedic device with product code MAX.

Frequently asked questions

What is the TxTi IBF System used for?

The TxTi IBF System is a titanium interbody fusion device designed for orthopedic applications. It features a Tetracell structure with up to 66% porosity and is integrated with HAnano Surface technology to enhance fusion capabilities while maintaining biocompatibility.

Is the TxTi IBF System single-use or reusable?

The TxTi IBF System is supplied as a single-use device, meaning it is designed for one-time use only and should not be reused on multiple patients to ensure safety and effectiveness.

What regulatory approvals does the TxTi IBF System have?

The TxTi IBF System has been cleared through the FDA Traditional 510(k) pathway with K183064 and is classified as substantially equivalent to predicate devices K180078 and K162496. It is a Class 2 Orthopedic device with product code MAX.

What are the key features of the TxTi IBF System?

The TxTi IBF System is made of titanium with up to 66% porosity and incorporates HAnano Surface technology. It features a Tetracell structure designed to enhance fusion capabilities while maintaining the biocompatible properties inherent to 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: TxTi — Innovasis, K183064 FDA 510 (k) - TxTi IBF System | Innovasis, Inc., PDF Marshall McCarty Director QA/RA Re: K183064 Trade/Device Name: TxTi IBF ..., Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Innovasis, Inc.

Sources (1)

  • FDA 510(k) K183064 24 fields · synced Sep 25, 2026