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Spinal Concepts Cadence and Traxis

by Spinal Concepts, Inc.

510(k) K033517

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 · Special NumberK033517 Date18 Feb 2004ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1343-04 FDA Unclassified (pre-2012) initiated 1 Apr 2004

    Handle becomes loose after repeated use.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Spinal Concepts Inc. Cadence and Traxis
510(k) Number
FDA Product Code
MQP
Device Class
Class II
Regulation
21 CFR Part 888.3060
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

Cadence and Traxis are hollow vertebral body replacement implants intended for use in the thoracic and thoracolumbar spine (T3‑L5). They are designed to replace a collapsed, damaged, or unstable vertebral body that has been resected or excised due to tumor, trauma, or other pathology, restoring biomechanical integrity of the anterior, middle, and posterior spinal columns.

The implants are supplied as sterile surgical devices for implantation during spine surgery. They were cleared by the FDA through a special 510(k) submission (K033517) as substantially equivalent to a predicate device. The clearance indicates compliance with applicable regulatory requirements for this class of orthopedic implant.

Other devices from Spinal Concepts, Inc.

See all devices from Spinal Concepts, Inc. →

Questions

AI-generated answers, 22 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 are Cadence and Traxis implants used for?

    Cadence and Traxis are hollow vertebral body replacement implants designed to replace collapsed, damaged, or unstable vertebral bodies in the thoracic and thoracolumbar spine (T3-L5) following resection due to tumor, trauma, or other pathology.

  • How are these implants supplied?

    The implants are supplied as sterile surgical devices intended for implantation during spine surgery, ensuring they meet applicable regulatory requirements for orthopedic implants.

  • What is the regulatory status of these implants?

    Cadence and Traxis received FDA clearance through a special 510(k) submission (K033517) as substantially equivalent to a predicate device, indicating compliance with regulatory requirements for this class of orthopedic implant.

  • Can these implants be reused?

    The device data does not specify whether Cadence and Traxis implants are single-use or reusable. Clinicians should consult the manufacturer's instructions for use to determine appropriate handling and sterilization protocols.