# K082128: Depuy Spine Lateral Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Spine
- Decided: Nov 14, 2008 after 108 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: 2 generations back to K071922 (2007). 3 ancestors in all.
933 later devices descend from it; 5 cite it directly.
1 of 937 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 1.
- K071795: Nuvasive Coroent System, Nuvasive, Inc. (2007) Summary page 1.

## Most influential descendants
- 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
- K113465: Acculif TL Cage (2011), 718 descendants of its own
- K113447: Rise Spacer (2012), 691 descendants of its own

## Indications for use
The Lateral Cage System is 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. The Lateral Cage System is intended for use with DePuy Spine supplemental fixation.

Source page: https://510kreport.com/device/K082128
Methodology: https://510kreport.com/methodology
