Transfx Intermediate External Fixation System, Transfx Small External Fixation System, Transfx Mini External Fixation

• 7 recalls, same reason

  • Terminated Z-1533-2009 FDA Unclassified (pre-2012) ·initiated 1 May 2009
  • Terminated Z-1537-2009 FDA Unclassified (pre-2012) ·initiated 1 May 2009
  • Terminated Z-1536-2009 FDA Unclassified (pre-2012) ·initiated 1 May 2009
  • Terminated Z-1538-2009 FDA Unclassified (pre-2012) ·initiated 1 May 2009
  • Terminated Z-1532-2009 FDA Unclassified (pre-2012) ·initiated 1 May 2009
  • Terminated Z-1534-2009 FDA Unclassified (pre-2012) ·initiated 1 May 2009
  • Terminated Z-1535-2009 FDA Unclassified (pre-2012) ·initiated 1 May 2009

  Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.

• • Terminated Z-0907-03 FDA Unclassified (pre-2012) ·initiated 10 Feb 2003

  Mislabeled; wrong identification number on pin.

510(k) Number

K990848 ↗

FDA Product Code

LXT

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Transfx External Fixation System

  Class II

  FDA 510(k) K984357 Active Cleared 4 Mar 1999

• Trans Fx Adjustable Pin to Bar Clamp

  Class II

  FDA 510(k) K001084 Active Cleared 15 Jun 2000

• Concert Radiopaque Bone Cement

  Class II

  FDA 510(k) K013755 Active Cleared 8 Feb 2002

• Transfx Multi Pin Clamp

  Class II

  FDA 510(k) K991723 Active Cleared 22 Jul 1999

• Concert Cranioplast

  Class II

  FDA 510(k) K023575 Active Cleared 22 Jan 2003

• External Fixation Anchor Pin

  Class II

  FDA 510(k) K001228 Active Cleared 7 Jul 2000

See all devices from Immedica, Inc. →

• What is the Transfx External Fixation System used for?

  This system is designed to provide skeletal stabilization for orthopedic fractures and reconstructive procedures. It functions by maintaining fracture reduction through an external frame that facilitates healing via rigid immobilization of bone segments.

• Who is authorized to apply this fixation system?

  The system is intended to be applied by surgeons within clinical or surgical settings to ensure proper placement and stabilization of the orthopedic appliance.

• What regulatory classification does this device hold?

  The Transfx External Fixation System is regulated as a Class II device under FDA 510(k) clearance K990848, which indicates it has been reviewed and cleared for use as a substantially equivalent device.

• What models are included in the Transfx system?

  The system includes the Transfx Intermediate External Fixation System, the Transfx Small External Fixation System, and the Transfx Mini External Fixation, providing options for various orthopedic stabilization needs.