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Kyphx Hv-R Bone Cement Model C01A

by Kyphon, Inc. 510(k)

Active United States

510(k) K041584

Overview

Kyphx Hv-R Bone Cement is a bone cement indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions. It is designed for use during balloon kyphoplasty procedures to provide controlled delivery of high-viscosity, doughy cement.

This device is authorized under FDA 510(k) clearance. It is supplied as a bone cement for clinical use in orthopedic procedures.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK041584 Date7 Jul 2004ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1624-2011 FDA Unclassified (pre-2012) initiated 10 Nov 2009
    • Terminated Z-1625-2011 FDA Unclassified (pre-2012) initiated 10 Nov 2009 via K041584, on the same 510(k)

    Product may not reach proper viscosity (dough state) and inconsistency or lack of homogeneity during cement preparation and during delivery period.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
NDN
Device Class
Class II
Regulation
21 CFR Part 888.3027
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the primary clinical use for Kyphx Hv-R Bone Cement?

    This bone cement is indicated for the treatment of pathological fractures of the vertebral body. These fractures may be caused by osteoporosis, cancer, or benign lesions, and the cement is specifically designed for use during balloon kyphoplasty procedures.

  • How is the cement delivered during a procedure?

    The device is designed to provide controlled delivery of a high-viscosity, doughy cement. This consistency is intended to facilitate the specific requirements of balloon kyphoplasty procedures.

  • What is the regulatory status of this device?

    Kyphx Hv-R Bone Cement, Model C01A, is authorized under FDA 510(k) clearance. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.