# K172967: Mercury® Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Elements, Inc.
- Decided: Apr 10, 2018 after 196 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: 10 generations back to K040583 (2004). 81 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 87 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 4.
- K083230: Mercury Spinal System, Spinal Elements, Inc. (2008) Summary page 4.
- K082353: Mercury Spinal System, Spinal Elements, Inc. (2009) Summary page 4.
- K091587: Mercury Spinal System, Spinal Elements, Inc. (2009) Summary page 4.
- K141372: Mercury Spinal System, Spinal Elements, Inc. (2014) Summary page 4.
- K151215: Mercury Spinal System, Spinal Elements, Inc. (2015) Summary page 4.

## Most influential descendants
- K222516: Mercury® II Spinal System (2022), 3 descendants of its own
- K243916: Primus Spinal Fixation System (2025), 2 descendants of its own
- K251154: RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments (2025), 1 descendant of its own
- K262193: RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology (2026), 0 descendants of its own
- K190981: NEX-D2 Posterior Fixation System (2020), 0 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 (T1-S1). Screws may be placed from the thoracic spine through the sacral spine and into the ilium. 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/K172967
Methodology: https://510kreport.com/methodology