# K032604: Gii Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Co-Ligne AG
- Decided: Jan 20, 2004 after 148 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: 3 generations back to K944736 (1995). 9 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 15 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.
- K980485: Isola Spinal System, Acromed Corp. (1998) Summary page 1.
- K010576: Monarch Spine System, Depuyacromed (2001)

## Most influential descendants
- K051089: Gii Spinal Fixation System (2005), 4 descendants of its own
- K192930: Dymaxeon Spine System (2020), 1 descendant of its own
- K083567: Gii Spinal Fixation System, Gii-TI-Poly Axial Screw (2009), 1 descendant of its own
- K243106: CarboClear® Hybrid Pedicle Screw System (2024), 0 descendants of its own
- K210306: GII Spinal Fixation System (2021), 0 descendants of its own

## Indications for use
When used as a pedicle screw fixation system in the non-cervical posterior spine in skeletally mature patients, the GII@ Spinal System is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the GII@ Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S 1) joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass. The GII system is also a hook and sacral/iliac screw fixation system of the non-cervical spine indicated for (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).

Source page: https://510kreport.com/device/K032604
Methodology: https://510kreport.com/methodology