Interpore Cross International Anterior Fixation Device (AFD)

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K022143 ↗

FDA Product Code

MQP

Device Class

Class II

Regulation

21 CFR Part 888.3060

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Altius Oct System

  Class II

  FDA 510(k) K033961 Active Cleared 14 Apr 2004

• Modification to Synergy Spinal System

  Class II

  FDA 510(k) K010515 Active Cleared 22 Mar 2001

• Pro Osteon Implant 500R Resorbable Bone Graft Substitute

  Class II

  FDA 510(k) K990131 Active Cleared 2 Mar 1999

• Ti Fenestrated Plate

  Class II

  FDA 510(k) K031772 Active Cleared 5 Sep 2003

• Telescopic Plate Spacer Thoracolumbar (Tps-Tl) Spinal System, Models 8123, 8124, 8132, 8133, 8156, 8157, 8158, & 8189

  Class II

  FDA 510(k) K020204 Active Cleared 21 Feb 2002

• Synergy Adjustable Length Rod

  Class II

  FDA 510(k) K990057 Active Cleared 28 Jun 1999

See all devices from Interpore Cross Intl. →

• What is the Interpore Cross AFD Anterior Fixation Device used for?

  The Interpore Cross AFD is designed for anterior spinal stabilization procedures. It provides internal fixation to support the vertebral column during healing, particularly in cases of spinal fractures or degenerative conditions. Unlike fusion devices, it aims to restore biomechanical integrity while maintaining spinal alignment without requiring spinal fusion.

• Is the Interpore Cross AFD Anterior Fixation Device reusable or single-use?

  The Interpore Cross AFD is supplied as a reusable surgical implant. It is intended for use in orthopedic settings under sterile conditions, meaning it can be cleaned, sterilized, and reused for subsequent procedures. This distinguishes it from single-use devices, which are discarded after one application.

• What regulatory pathway does the Interpore Cross AFD follow?

  The device follows the FDA 510(k) clearance pathway, specifically under traditional review standards. It was granted clearance (K022143) as substantially equivalent to a predicate device, adhering to Class II special controls for spinal devices. This classification ensures it meets stringent regulatory requirements for safety and effectiveness in spinal stabilization.

• How is the Interpore Cross AFD Anterior Fixation Device supplied?

  The device is supplied in a sterile package, ready for surgical use in orthopedic settings. Since it is reusable, it must be cleaned and sterilized between uses to maintain its integrity and prevent contamination. Proper sterilization protocols are critical to ensure its safety and functionality for repeated applications.

• Does the Interpore Cross AFD have any specific MRI safety considerations?

  The available data does not provide explicit MRI safety information for the Interpore Cross AFD. Clinicians should consult manufacturer guidelines or additional documentation to determine compatibility with MRI procedures, as some metallic implants may pose risks in magnetic fields.