Fixion Intramedullary Nailing System (Fixion Im Nailing System)

• • Terminated Z-0943-03 FDA Unclassified (pre-2012) ·initiated 11 Dec 2002 ·on shared 510(k) K021324

  The Fixion Interlocking Proximal Femoral Hip Pegs are defective due to possible tension failure.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K021324 ↗

FDA Product Code

HSB

Device Class

Class II

Regulation

21 CFR Part 888.3020

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Fixion Intramedullary Nailing System (Fixion Im Nail)

  Class II

  FDA 510(k) K003212 Active Cleared 28 Dec 2000

• Sky Bone Expander System (Sky System)

  Class II

  FDA 510(k) K040612 Active Cleared 17 Jun 2004

• Fixion Interlocking Nail (Fixion Il Nail)

  Class II

  FDA 510(k) K002783 Active Cleared 5 Dec 2000

• Fixion Interlocking Proximal Femoral Nailing System

  Class II

  FDA 510(k) K010988 Active Cleared 19 Jun 2001

• Fixion Unipolar Modular Hemi-Hip System (Fixion Uh)

  Class II

  FDA 510(k) K014072 Active Cleared 8 Mar 2002

• Modification to Fixion Intramedullary Nailing System (Fixion Im)

  Class II

  FDA 510(k) K032588 Active Cleared 12 Sep 2003

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