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TranS1 AxiaLIF Plus System

by Trans1

510(k) K192792

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK192792 Date20 Nov 2019ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KWQ
Device Class
Class II
Regulation
21 CFR Part 888.3060
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The TranS1 AxiaLIF Plus System is a device designed to provide anterior stabilization of the L5-S1 or L4-S1 spinal segment(s) as an adjunct to spinal fusion. It is indicated for patients requiring fusion to treat pseudoarthrosis (unsuccessful previous fusion), spinal stenosis, spondylolisthesis (Grade 1 or 2 if single-level; Grade 1 if two-level), or degenerative disc disease.

The system is supplied as a non-sterile, reusable instrument set intended for use in a hospital operating room setting. It requires sterilization prior to use and is not MRI safe. No specific sizes or storage conditions are provided in the data. The device received FDA 510(k) clearance under K192792 with product code KWQ and was determined to be substantially equivalent to a predicate device.

Other devices from Trans1

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the TranS1 AxiaLIF Plus System used for?

    The TranS1 AxiaLIF Plus System is designed to provide anterior stabilization of the L5-S1 or L4-S1 spinal segment(s) as an adjunct to spinal fusion. It is indicated for patients requiring fusion to treat pseudoarthrosis, spinal stenosis, spondylolisthesis (Grade 1 or 2 if single-level; Grade 1 if two-level), or degenerative disc disease.

  • Is the TranS1 AxiaLIF Plus System sterile when supplied?

    The system is supplied as a non-sterile, reusable instrument set. It requires sterilization prior to use in a hospital operating room setting, as it is not provided in a sterile condition.

  • Can the TranS1 AxiaLIF Plus System be reused after sterilization?

    Yes, the TranS1 AxiaLIF Plus System is intended as a reusable instrument set. It is designed for multiple uses after proper sterilization, as it is supplied non-sterile and meant to be reprocessed between procedures.

  • What regulatory pathway was used for the TranS1 AxiaLIF Plus System?

    The device received FDA 510(k) clearance under K192792 with product code KWQ and was determined to be substantially equivalent to a predicate device through a traditional 510(k) submission.