# K083567: Gii Spinal Fixation System, Gii-TI-Poly Axial Screw

- Pathway: 510(k) (Special)
- Applicant: Co-Ligne AG
- Decided: Sep 14, 2009 after 285 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- 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: 5 generations back to K944736 (1995). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980852: Gii Spinal Fixation System, Karen E. Warden, M.E.B.E. (1998) Summary page 1.
- K032604: Gii Spinal Fixation System, Co-Ligne AG (2004) Summary page 1.
- K051089: Gii Spinal Fixation System, Co-Ligne AG (2005) Summary page 1.

## Most influential descendants
- K210306: GII Spinal Fixation System (2021), 0 descendants of its own

## Indications for use
The GII spinal fixation system when used as a pedicle screw system in the non-cervical posterior spine, the GII spinal fixation system is to be used in skeletally-mature patients as an adjunct to fusion using autograft and/or allograft for one or more of the following: (1) Degenerative or severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar/first sacral (L5-SI) joint with objective evidence of neurologic impairment, (2)Fracture, (3) Dislocation, (4) Scoliosis, (5) Kyphosis, (6) Spinal tumor, and/or (7)Failed previous fusion (pseudoarthrosis). The GII spinal fixation system when used as a hook and sacral/iliac screw fixation system in the non-cervical posterior spine, the GII spinal fixation system is to be used in skeletally mature patients as an adjunct to fusion using autograft and/or allograft for one or more of the following: (1)Degenerative spondylolisthesis with objective evidence of neurologic impairment, (2)Fracture, (3)Dislocation, (4)Scoliosis, (5)Kyphosis, (7)Spinal tumor, and/or (8)Failed previous fusion (pseudoarthrosis).

Source page: https://510kreport.com/device/K083567
Methodology: https://510kreport.com/methodology