Kyphon Inflatable Bone Tamp

• 3 recalls, same reason

  • Terminated Z-2389-2020 FDA Class II ·initiated 24 Apr 2020
  • Terminated Z-2390-2020 FDA Class II ·initiated 24 Apr 2020
  • Terminated Z-2391-2020 FDA Class II ·initiated 24 Apr 2020

  Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required surgical and anesthesia time for the patient. If the device seeps or creeps from its intended position prior to setting and creates incomplete void or gap filling, possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.

510(k) Number

K981251 ↗

FDA Product Code

HRX

Device Class

Class II

Regulation

21 CFR Part 888.1100

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01B

  Class II

  FDA 510(k) K063071 Active Cleared 13 Apr 2007

• Discyphor Direct Catheter System, Discyphor Direct Needles, Long, Discyphor Direct Needles, Regular

  Class II

  FDA 510(k) K073516 Active Cleared 21 Feb 2008

• Kyphx Hv-R Bone Cement Model C01A

  Class II

  FDA 510(k) K041584 Active Cleared 7 Jul 2004

• Kyphx Hv-R, Model C01A

  Class II

  FDA 510(k) K033801 Active Cleared 1 Apr 2004

• Kyphx Inflatable Bone Tamp, Size 20/3, Model K01A, Kyphx Inflatable Bone Tamp, Size 15/3, Model K02A

  Class II

  FDA 510(k) K010246 Active Cleared 14 Feb 2001

• Functional Anaesthetic Discography (Fad) Catheter System, Model D01A ; Introducer Needle, Model D01B

  Class II

  FDA 510(k) K061210 Active Cleared 27 Jun 2006

See all devices from Kyphon, Inc. →

• What is the Kyphon Inflatable Bone Tamp used for?

  The Kyphon Inflatable Bone Tamp is a surgical instrument designed for orthopedic procedures to reduce fractures or create voids in cancellous bone. It features a double-lumen catheter with an inflatable distal component and radiopaque marker bands.

• Is the Kyphon Inflatable Bone Tamp reusable or single-use?

  The Kyphon Inflatable Bone Tamp is supplied as a single-use instrument and is intended for use in surgical settings only. It should not be reused on multiple patients due to sterility and structural integrity concerns.

• What are the key features of the Kyphon Inflatable Bone Tamp?

  The device consists of a double-lumen catheter with an inflatable distal component and radiopaque marker bands. It is designed to withstand higher forces during inflation for fracture reduction procedures, making it suitable for various orthopedic applications.

• What is the regulatory status of the Kyphon Inflatable Bone Tamp?

  The Kyphon Inflatable Bone Tamp is authorized under FDA 510(k) clearance with product code HRX. It received traditional clearance on July 2, 1998, and is classified as substantially equivalent to predicate devices in the orthopedic category.