# K052384: Lanx VBR System

- Pathway: 510(k) (Traditional)
- Applicant: Lanx, LLC
- Decided: Oct 7, 2005 after 38 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: 5 generations back to K841189 (1984). 12 ancestors in all.
455 later devices descend from it; 3 cite it directly.
0 of 468 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003709: Surgical Dynamics Mesh Cage System, United States Surgical, A Division of Tyco Healthc (2001) Summary page 1.
- K001340: Stackable Cage System, Depuyacromed (2000) Summary page 3.
- K040928: Expandable Peek VBR Implant, Interpore Cross Intl. (2004) Summary page 1.
- K042268: Ebi Cas Spine Spacer System, Ebi, L.P. (2004) Summary page 1.

## Most influential descendants
- K083815: Lanx Fusion System (2009), 451 descendants of its own
- K102738: Lanx Fusion System (2011), 328 descendants of its own
- K123767: Lanx Fusion System- SA (2013), 324 descendants of its own
- K131122: S128 Anterior Lumbar Interbody Fusion (Alif) System (2013), 269 descendants of its own
- K140106: S128 Anterior Lumbar Interbody Fusion (Alif) System (2014), 265 descendants of its own

## Indications for use
The Lanx VBR System is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for usc as a vertebral body replacement in the thoracolumbar spine (from TI to L5) The Lanx VBR System may also be used in the thoracolumbar spine (i.e., Ti- L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body, The Lanx VBR System is also indicated for treating fractures of the thoracic and lumbar spine. The Lanx VBR System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column. For either indication the system must be used with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system.

Source page: https://510kreport.com/device/K052384
Methodology: https://510kreport.com/methodology