# K090899: Depuy Spine Lateral System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Spine, Inc.
- Decided: May 19, 2009 after 48 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K841189 (1984). 16 ancestors in all.
932 later devices descend from it; 5 cite it directly.
1 of 949 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082128: Depuy Spine Lateral Cage System, Depuy Spine (2008) Summary page 1.
- K041722: Modification to VBR Spinal System, Depuy Spine, Inc. (2004) Summary page 1.
- K052746: Concorde VBR Spinal System, Depuy Spine, Inc. (2005) Summary page 1.
- K001340: Stackable Cage System, Depuyacromed (2000) Summary page 1.
- K013382: Modification to: Stackable Cage System, Depuyacromed (2001) Summary page 1.

## Most influential descendants
- K093242: Patriot Transcontinental Llif Spacer (2009), 921 descendants of its own
- K102293: Caliber Spacer (2011), 869 descendants of its own
- K113465: Acculif TL Cage (2011), 718 descendants of its own
- K113447: Rise Spacer (2012), 691 descendants of its own
- K121683: Acculif TL Cage (2012), 682 descendants of its own

## Indications for use
The Lateral Cage System is indicated for use in the thoracolumbar spine (i.e., Ti 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. This system is also indicated for treating fractures of the thoracic and lumbar spine. The system is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column evefinithe absence of fusion for a prolonged period. When used as a vertebral body replacement device, this system is intended for use with DePuy Spine supplemental internal fixation. The Lateral Cage System is also indicated for intervertebral body fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from. L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.'These implants may be implanted via an open or a minimally invasive lateral approach. When used as an interbody fusion device, this system is intended for use with DePuy Spine supplemental.internal fixation.

Source page: https://510kreport.com/device/K090899
Methodology: https://510kreport.com/methodology