# K073502: Vertebron VBR System

- Pathway: 510(k) (Traditional)
- Applicant: Vertebron, Inc.
- Decided: Mar 24, 2008 after 102 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: 9 generations back to K841189 (1984). 27 ancestors in all.
12 later devices descend from it; 7 cite it directly.
1 of 40 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073144: Lanx Intervertebral Body Fusion Device, Lanx, LLC (2008). Cleared while this submission was under review Summary page 1.
- K072970: Patriot Spacers, Globus Medical, Inc. (2008). Cleared while this submission was under review Summary page 1.
- K072120: Paramount Intervertebral Body Fusion Device, Innovative Spinal Technologies, Inc. (2007) Summary page 1.
- K073202: Ardis Spacer, Abbott Spine, Inc. (2008). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K160976: Altus Spine Interbody Fusion System (2017), 8 descendants of its own
- K170512: Altus Spine Titanium Interbody Fusion System (2017), 6 descendants of its own
- K171329: Altus Spine Titanium Interbody Fusion System (2017), 2 descendants of its own
- K141443: Infront Lumbar Interbody Fusion System (2014), 2 descendants of its own
- K182406: Altus Spine Interbody Fusion System (2019), 1 descendant of its own

## Indications for use
The VERTEBRON Interbody Fusion System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The VERTEBRON Interbody Fusion System is implanted via an anterior or posterior approach and is to be combined with cleared supplemental fixation systems, such as the VERTEBRON PSS Pedicle Screw System.

Source page: https://510kreport.com/device/K073502
Methodology: https://510kreport.com/methodology