Fixion Interlocking Proximal Femoral Intramedullary Nailing System

• • Terminated Z-0943-03 FDA Unclassified (pre-2012) ·initiated 11 Dec 2002 ·on shared 510(k) K012967

  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.

Full name

Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing System

510(k) Number

K012967 ↗

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

See all devices from Disc-O-Tech Medical Technologies, Ltd. →

• What is the Fixion Interlocking Proximal Femoral Intramedullary Nailing System used for?

  This system is designed specifically for internal fixation of proximal femoral fractures. It stabilizes diaphyseal fractures and short distal or proximal fragments in the femur by providing mechanical support through intramedullary placement of an interlocking nail and screws. This promotes proper bone alignment and facilitates healing during orthopedic procedures.

• Is the Fixion Intramedullary Nailing System supplied as a reusable or single-use device?

  The Fixion Interlocking Proximal Femoral Intramedullary Nailing System is supplied as a reusable surgical instrument set. It is intended for use in multiple procedures under sterile conditions, adhering to standard orthopedic surgical protocols for handling and reprocessing.

• What sterility and handling requirements apply to this device?

  The system must be handled under sterile conditions during surgical procedures, as it is intended for orthopedic use. While the device itself is reusable, all components must be properly cleaned, sterilized, and inspected before reuse to ensure safety and efficacy. Storage and handling follow regulatory guidelines for orthopedic fixation devices.

• Can this device be used with MRI imaging?

  No, the Fixion Interlocking Proximal Femoral Intramedullary Nailing System is explicitly not indicated for MRI use. This restriction is due to potential interference or safety risks associated with magnetic resonance imaging.

• What regulatory pathway was followed for this device’s clearance?

  The Fixion system received a Special 510(k) clearance through the FDA’s Orthopedic (OR) Advisory Committee. The classification aligns with intramedullary rods and fixation accessories for long bone stabilization, and the device was determined to be substantially equivalent to a predicate under the FDA’s product code HSB.