# K052170: Seaspine VBR System

- Pathway: 510(k) (Traditional)
- Applicant: Seaspine, Inc.
- Decided: Dec 21, 2005 after 134 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: 7 generations back to K841189 (1984). 27 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050553: Novel VBR Spinal System, Alphatec/Nexmed (2005) Summary page 1.
- K042201: Novel VBR Spinal System, Alphatec/Nexmed (2004) Summary page 1.
- K010530: Geo Structure, Interpore Cross Intl. (2001) Summary page 1.
- K020048: Modification to Geo Structure, Interpore Cross Intl. (2002) Summary page 1.
- K040168: Modification to Geo Structure, Interpore Cross Intl. (2004) Summary page 1.
- K050449: Quantum Vertebral Body Replacement, Quantum Orthopedics, Inc. (2005) Summary page 1.
- K033517: Spinal Concepts Inc. Cadence and Traxis, Spinal Concepts, Inc. (2004) Summary page 1.

## Most influential descendants
- K071726: ZUMA (2007), 12 descendants of its own
- K124034: Mectalif Anterior (2013), 11 descendants of its own
- K160605: MectaLIF Anterior Stand-Alone (2016), 10 descendants of its own
- K170455: MectaLIF Anterior Stand Alone (2017), 4 descendants of its own
- K221545: MectaLIF Anterior Extension (2022), 2 descendants of its own

## Indications for use
The SeaSpine VBR System is intended for use in the thoracolumbar spine (TI to L5) to replace a collapsed, diseased, damaged or unstable complete or partial vertebral body due to tumor or trauma/fracture, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The SeaSpine VBR 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. Additionally, the SeaSpine VBR System is intended for use with bone graft.

Source page: https://510kreport.com/device/K052170
Methodology: https://510kreport.com/methodology