# K980852: Gii Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Karen E. Warden, M.E.B.E.
- Decided: May 1, 1998 after 57 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
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K032604: Gii Spinal Fixation System (2004), 5 descendants of its own
- 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

## Indications for use
The GII Spinal Fixation System using pedicle screws is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. The levels of pedicle screw fixation may be from L3 to the sacrum.

Source page: https://510kreport.com/device/K980852
Methodology: https://510kreport.com/methodology