# K030833: Depuy Acromed VBR System

- Pathway: 510(k) (Special)
- Applicant: Depuyacromed
- Decided: Apr 10, 2003 after 24 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K841189 (1984). 7 ancestors in all.
1,224 later devices descend from it; 7 cite it directly.
1 of 1,232 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990148: Stackable Cage System, Depuy Motech Acromed (1999) Summary page 1.
- K001340: Stackable Cage System, Depuyacromed (2000) Summary page 1.
- K003043: Surgical Titanium Mesh System, Depuyacromed (2001) Summary page 1.
- K020522: Modification to Surgical Titanium Mesh System, Depuyacromed (2002) Summary page 1.
- K023835: Devex Mesh System, Depuyacromed (2003) Summary page 1.

## Cited in the summary but kept off the family tree
- K034209: Surgical Titanium Mesh System. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K031635: Depuy Acromed VBR System (2003), 1,201 descendants of its own
- K041722: Modification to VBR Spinal System (2004), 1,150 descendants of its own
- K052746: Concorde VBR Spinal System (2005), 1,149 descendants of its own
- K081917: Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems (2009), 1,008 descendants of its own
- K090899: Depuy Spine Lateral System (2009), 932 descendants of its own

## Indications for use
The DePuy AcroMed VBR System is indicated for use in the thoracolumbar spine (i.e., T I to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The DePuy AcroMed VBR System is also indicated for treating fractures of the thoracic and lumbar spine. The DePuy AcroMed VBR System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The DePuy AcroMed VBR System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the VBR System include DePuy AcroMed titanium plate or rod systems (Le., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Monarch, and Profile).

Source page: https://510kreport.com/device/K030833
Methodology: https://510kreport.com/methodology