# K071726: ZUMA

- Pathway: 510(k) (Traditional)
- Applicant: Seaspine, Inc.
- Decided: Oct 23, 2007 after 120 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: 8 generations back to K841189 (1984). 30 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052170: Seaspine VBR System, Seaspine, Inc. (2005) Summary page 1.
- K062083: Synfix -LR, Synthes Spine Co.Lp (2007) Summary page 1.

## Most influential descendants
- 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
- K232123: MectaLIF Anterior Lag Extension (2023), 1 descendant of its own

## Indications for use
The Zuma 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 Zuma 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 Zuma System is intended for use with bone graft.

Source page: https://510kreport.com/device/K071726
Methodology: https://510kreport.com/methodology