Fixion Interlocking Proximal Femoral Nailing System

• • Terminated Z-0943-03 FDA Unclassified (pre-2012) ·initiated 11 Dec 2002 ·on shared 510(k) K010988

  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

K010988 ↗

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 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

• Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion Pf Nailing System), Fixion Intramedullary Nail

  Class II

  FDA 510(k) K023437 Active Cleared 14 Nov 2002

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

• What clinical situation is the Fixion Interlocking Proximal Femoral Nailing System designed for?

  It is intended to stabilize fractures of the femur by providing an intramedullary fixation rod with interlocking screws. The design allows for load sharing across the fracture site, promoting alignment and early mobilization in orthopedic trauma patients.

• What components are included in the system and how are they supplied?

  The system comprises a proximal femoral nail, a set of interlocking screws, insertion guides, and ancillary instrumentation. All components are packaged together as a single kit, ensuring that the surgeon has the complete set needed for implantation without ordering separate parts.

• Is the device supplied sterile and is it intended for single‑use or multiple‑use?

  Yes, the nail and all accessories are provided in a sterile, sealed package. The device is classified as a single‑use product; after implantation the entire assembly is discarded to maintain sterility and prevent cross‑contamination.

• Are there different sizes or models of the Fixion nail available?

  The product data does not list specific size variations, but intramedullary nails are typically offered in a range of lengths and diameters to match patient anatomy. Clinicians should consult the manufacturer’s catalog for the exact size options that correspond to the Fixion system.

• What regulatory pathway was used for the Fixion system’s clearance?

  The Fixion Interlocking Proximal Femoral Nailing System received clearance through the FDA 510(k) pathway (K010988) using a traditional review process. It was deemed substantially equivalent to a predicate device and classified as a Class II device with special controls under product code HSB.