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Uni-T Spinal System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K013301

by Spine Vision, Inc.

Identifiers

510(k) Number
K013301 FDA 510(k)
FDA Product Code
MNI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3070 FDA 510(k)
Regulation Number
888.3070 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The UNI-T Uni-Thread Spinal System is a posterior spinal fixation device classified as an orthopedic spinal fixation system. It consists of titanium alloy screws, rods, and connectors designed to immobilize and stabilize spinal segments during surgical fusion procedures, addressing pathologies such as deformities and instability in the thoracic, lumbar, and sacral spine.

This system is assembled into customizable constructs for implantation during surgery and is supplied as a reusable surgical instrument set. Components are manufactured from titanium alloy per ASTM F136 standards and are intended for single-use implantation. The device holds FDA 510(k) clearance under the traditional review pathway, with a product code of MNI, and is intended for use in orthopedic spinal procedures.

Frequently asked questions

What types of spinal conditions is the UNI-T Spinal System designed to address during surgery?

The UNI-T Uni-Thread Spinal System is specifically designed to stabilize and immobilize spinal segments during surgical fusion procedures for pathologies like deformities and instability. It is intended for use in the thoracic, lumbar, and sacral regions of the spine, helping to correct structural issues and promote proper alignment during recovery.

Is the UNI-T Spinal System reusable or single-use, and how are its components supplied?

The UNI-T Spinal System components—titanium alloy screws, rods, and connectors—are intended for single-use implantation after surgery. However, the system is supplied as a reusable surgical instrument set, meaning the tools used to assemble the device in the operating room are designed for repeated use, while the implanted hardware itself is not.

What materials are used in the UNI-T Spinal System, and what standards do they meet?

The UNI-T Spinal System components are manufactured from titanium alloy and comply with ASTM F136 standards, ensuring durability, biocompatibility, and structural integrity for spinal fixation applications.

How is the UNI-T Spinal System assembled, and can it be customized for different spinal procedures?

The UNI-T Spinal System is assembled into customizable constructs during surgery, allowing surgeons to tailor the configuration of screws, rods, and connectors to match the specific anatomical needs of the patient. This modular design supports flexibility in addressing thoracic, lumbar, and sacral spinal pathologies.

What regulatory pathway was followed for FDA clearance of the UNI-T Spinal System, and what does that mean for its use?

The UNI-T Spinal System received FDA 510(k) clearance under the traditional review pathway, meaning its safety and effectiveness were compared to a legally marketed predicate device. This clearance confirms it meets regulatory standards for orthopedic spinal fixation and can be legally marketed and used in the U.S. for its intended surgical applications.

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: PDF K013301 - accessdata.fda.gov, UNI-T SPINAL SYSTEM (K013301) — FDA 510 (k) | Innolitics, UNI-T UNI-THREAD SPINAL SYSTEM (K021510) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Spine Vision, Inc.

Sources (1)

  • FDA 510(k) K013301 24 fields · synced Sep 19, 2026