# K161516: G Surgical Marksman MIS System

- Pathway: 510(k) (Traditional)
- Applicant: G Surgical, LLC
- Decided: Aug 25, 2016 after 84 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 K980447 (1998). 97 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 101 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122901: Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation System, Orthofix (2012) Summary page 5.
- K100685: Zodiac Polyaxial Spinal Fixation System, Alphatec Spine, Inc. (2010) Summary page 5.
- K022623: 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System), Depuyacromed (2002) Summary page 5.
- K051971: Optima Spinal System, U&I Corp. (2005) Summary page 5.

## Most influential descendants
- K193219: G Surgical Marksman System (2019), 1 descendant of its own
- K240737: G Surgical Marksman MIS System (2024), 0 descendants of its own
- K230063: G Surgical Marksman Spinal Deformity System (2023), 0 descendants of its own

## Indications for use
The G Surgical Marksman MIS 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. The G Surgical Marksman MIS System can be used in an open approach or a percutaneous approach with MIS instrumentation.

Source page: https://510kreport.com/device/K161516
Methodology: https://510kreport.com/methodology