# K041722: Modification to VBR Spinal System

- Pathway: 510(k) (Special)
- Applicant: Depuy Spine, Inc.
- Decided: Sep 23, 2004 after 91 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: 6 generations back to K841189 (1984). 9 ancestors in all.
1,150 later devices descend from it; 3 cite it directly.
1 of 1,160 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030833: Depuy Acromed VBR System, Depuyacromed (2003) Summary page 1.
- K031635: Depuy Acromed VBR System, Depuyacromed (2003) Summary page 1.
- K990148: Stackable Cage System, Depuy Motech Acromed (1999) Summary page 1.
- K020522: Modification to Surgical Titanium Mesh System, Depuyacromed (2002) Summary page 1.
- K023835: Devex Mesh System, Depuyacromed (2003) Summary page 1.

## Most influential descendants
- 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
- K093242: Patriot Transcontinental Llif Spacer (2009), 921 descendants of its own
- K102293: Caliber Spacer (2011), 869 descendants of its own

## Indications for use
The indications for use for the modified devices described in this submission are the same as those for the DePuy AcroMed VBR System. The indications are as follows: The VBR Spinal System is indicated for use in the thoracolumbar spine (i.e., T1-5) 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 VBR Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The VBR Spinal 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 VBR Spinal System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the VBR Spinal System include DePuy Spine titanium plate or rod systems (i.e., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, MONARCH, and Profile).

Source page: https://510kreport.com/device/K041722
Methodology: https://510kreport.com/methodology