Modification to Fixion Interlocking Intramedullary Nailing System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K013449 ↗

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 Modification to Fixion Interlocking Intramedullary Nailing System used for?

  It is used for internal fixation of bone fractures, specifically diaphyseal fractures and short distal or proximal fractures, by stabilizing bone fragments via insertion into the medullary canal as an orthopedic fixation rod.

• What materials are the components of this system made from?

  The system consists of stainless steel nails and hip pegs, which are designed for durability and biocompatibility in internal bone fracture fixation procedures.

• Who uses this device and in what setting?

  Orthopedic surgeons use this device in clinical or surgical settings to perform internal fixation of fractures, particularly in long bones where medullary canal stabilization is required.

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

  The device received FDA 510(k) clearance through a traditional review process, determined to be substantially equivalent to a predicate device under K013449, cleared on December 19, 2001.

• What product code classifies this device and what does it signify?

  The device is classified under product code HSB, which corresponds to Class II devices requiring special controls, specifically for rod, fixation, intramedullary and accessories.