# K091587: Mercury Spinal System

- Pathway: 510(k) (Special)
- Applicant: Spinal Elements, Inc.
- Decided: Jul 1, 2009 after 29 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- 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 K040583 (2004). 68 ancestors in all.
10 later devices descend from it; 5 cite it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071914: Mercury Spinal System, Spinal Elements, Inc. (2007) Summary page 2.
- K082353: Mercury Spinal System, Spinal Elements, Inc. (2009) Summary page 2.
- K083230: Mercury Spinal System, Spinal Elements, Inc. (2008) Summary page 2.
- K984251: Xia Spine System, Howmedica, Inc. (1999) Summary page 2.

## Most influential descendants
- K141372: Mercury Spinal System (2014), 9 descendants of its own
- K151215: Mercury Spinal System (2015), 8 descendants of its own
- K191576: Mercury® Spinal System, Overwatch® Spinal System (2019), 5 descendants of its own
- K172967: Mercury® Spinal System (2018), 5 descendants of its own
- K222516: Mercury® II Spinal System (2022), 3 descendants of its own

## Indications for use
The Mercury Spinal System is intended to provide immobilization and stabilization of the spine in skeletally mature patients as an adjunct to fusion for procedures of the thoracic, lumbar, and sacral spine (Ti-Si). This system is intended for anterior/anterolateral non-pedicle fixation, posterior non-pedicle fixation, and posterior pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal. stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. This system is intended to be used with bone graft.

Source page: https://510kreport.com/device/K091587
Methodology: https://510kreport.com/methodology