# K191576: Mercury® Spinal System, Overwatch® Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Elements, Inc.
- Decided: Sep 16, 2019 after 94 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: 16 generations back to K040583 (2004). 250 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 256 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161842: Overwatch Spine System, Amendia, Inc. (2016) Summary page 6.
- K083230: Mercury Spinal System, Spinal Elements, Inc. (2008) Summary page 6.
- K091587: Mercury Spinal System, Spinal Elements, Inc. (2009) Summary page 6.
- K141372: Mercury Spinal System, Spinal Elements, Inc. (2014) Summary page 6.
- K151215: Mercury Spinal System, Spinal Elements, Inc. (2015) Summary page 6.

## 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
- K193472: OrthoCircle Spine Pedicle Screw System (2020), 0 descendants of its own

## Indications for use
The Mercury® and Overwatch® Spinal Systems are 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 (Tl -S1). Screws may be placed from the thoracic spine through the sacral spine and into the ilium. These systems are 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. These systems are intended to be used with bone graft. The Spinal Elements Mercury Fixation System may be used in conjunction with the Spinal Elements Overwatch System. In order to achieve additional levels of fixation, the Mercury or Overwatch Fixation Systems may be connected to the Lotus Posterior Cervical/Thoracic rod connectors. Transition rods with differing diameters may also be used to connect the Lotus Posterior Cervical/Thoracic Spinal System to the Mercury or Overwatch Spinal Systems. Refer to the Lotus Posterior Cervical/Thoracic Spinal System package insert for a list of Lotus indications for use. When used for posterior non-cervical pedicle screw fixation in pediatric patients the Mercury and Overwatch implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Source page: https://510kreport.com/device/K191576
Methodology: https://510kreport.com/methodology