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KYPHON ELEMENT Inflatable Bone Tamp

by Medtronic, Inc.

510(k) K151532

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 NumberK151532 Date23 Jul 2015ClearedStatusActive

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  • Withdrawn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
HRX
Device class
Class II
Regulation
21 CFR Part 888.1100
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Kyphon Element Inflatable Bone Tamp is an orthopedic balloon system designed for the reduction of fractures and the creation of a void in cancellous bone within the spine. It functions as a conventional bone tamp and is intended for use during balloon kyphoplasty procedures involving cleared PMMA-based bone cement.

This device is authorized under FDA 510K clearance. It is utilized in orthopedic settings for the treatment of vertebral compression fractures.

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Questions

AI-generated answers, 25 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 primary clinical use of the Kyphon Element Inflatable Bone Tamp?

    This device is designed for use in orthopedic settings to treat vertebral compression fractures. It functions by creating a void in the cancellous bone of the spine and assisting in the reduction of fractures during balloon kyphoplasty procedures.

  • Is the Kyphon Element Inflatable Bone Tamp compatible with bone cement?

    Yes, the device is intended for use during balloon kyphoplasty procedures that involve the application of cleared PMMA-based bone cement to stabilize the vertebral body after the void has been created.

  • What is the regulatory status of this orthopedic device?

    The Kyphon Element Inflatable Bone Tamp is authorized under FDA 510K clearance, having been determined to be substantially equivalent to existing devices through the traditional review process.