Depuy Acromed Vbr System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K031635 ↗

FDA Product Code

MQP

Device Class

Class II

Regulation

21 CFR Part 888.3060

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Moss Miami Spinal Systems

  Class II

  FDA 510(k) K013296 Active Cleared 9 Oct 2001

• Monarch Spine System

  Class II

  FDA 510(k) K021335 Active Cleared 11 Jul 2002

• Eagle Anterior Cervial Plate System

  Class II

  FDA 510(k) K040197 Active Cleared 2 Apr 2004

• Stackable Cage System

  Class II

  FDA 510(k) K001340 Active Cleared 26 Jul 2000

• Depuy Acromed Vbr System

  Class II

  FDA 510(k) K030833 Active Cleared 10 Apr 2003

• Crossover Cross Connector (Moss Miami Spine System)

  Class II

  FDA 510(k) K021880 Active Cleared 26 Jun 2002

See all devices from Depuyacromed →

• What is the DePuy Acromed VBR System used for in spinal surgery?

  The DePuy Acromed VBR System is designed to replace fractured or diseased vertebral bodies in the thoracic and lumbar spine, restoring spinal biomechanical integrity. It provides structural support without requiring spinal fusion, making it suitable for cases where a vertebral body needs to be replaced to maintain proper spinal alignment and stability.

• Is the DePuy Acromed VBR System intended for reuse or is it single-use?

  The DePuy Acromed VBR System is explicitly supplied as a sterile, single-use device. This means it is intended for one-time surgical use only and should not be reused after implantation, as reuse could compromise sterility and patient safety.

• How is the DePuy Acromed VBR System regulated by the FDA?

  The system holds an FDA 510(k) clearance (K031635) with a Special Review designation, classified under the Orthopedic Advisory Committee (OR). This means its safety and effectiveness were compared to a legally marketed predicate device, and it was determined to be substantially equivalent to that predicate. The clearance was granted in 2003.

• What types of spinal regions is the DePuy Acromed VBR System intended for?

  The system is specifically designed for use in the thoracic and lumbar spine, where it replaces vertebral bodies to restore structural integrity. It is not indicated for cervical spine applications or other spinal regions unless explicitly stated in updated documentation.

• How should the DePuy Acromed VBR System be stored before use?

  Since the system is sterile and single-use, it must be stored in its original packaging under conditions that maintain sterility until the time of surgery. Proper storage typically involves keeping it in a clean, dry environment away from direct sunlight or extreme temperatures, as recommended by the manufacturer’s instructions.