# K193219: G Surgical Marksman System

- Pathway: 510(k) (Special)
- Applicant: G Surgical, LLC
- Decided: Dec 17, 2019 after 26 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 K853033 (1985). 259 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 261 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161516: G Surgical Marksman MIS System, G Surgical, LLC (2016) Summary page 4.
- K081041: GPS, G Surgical Pedicle System, G Surgical Co., Ltd. (2008) Summary page 4.
- K133369: Tiger Spine System, Corelink, LLC (2014) Summary page 4.
- K022623: 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System), Depuyacromed (2002) Summary page 4.
- K051971: Optima Spinal System, U&I Corp. (2005) Summary page 4.

## Most influential descendants
- K230063: G Surgical Marksman Spinal Deformity System (2023), 0 descendants of its own

## Indications for use
The G Surgical Marksman System is intended to provide immobilization and stabilization of the posterior non-cervical spine (T1-S2/Ilium) in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (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, pseudarthrosis, and/or failed previous fusion.

Source page: https://510kreport.com/device/K193219
Methodology: https://510kreport.com/methodology