# K113755: Savannah Technologies Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Savannah Technologies, LLC
- Decided: Feb 1, 2012 after 42 days
- Product code: MNI (Orthosis, Spinal Pedicle 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 K901587 (1990). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092420: KRD1 Pedicle Screw System, Spinefrontier, Inc. (2009) Summary page 1.
- K042673: Zodiac Polyaxial Spinal Fixation System, Alphatec/Nexmed (2004) Summary page 1.
- K990118: Isobar Spinal System, Scien'Tx USA, Inc. (1999) Summary page 1.

## Cited in the summary but kept off the family tree
- K013444: Isobar Spinal System, Scien'Tx USA, Inc. (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Savannah Technologies Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). When used as a pedicle screw system, the Savannah Technologies Spinal System is intended for the treatment of severe 'spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

Source page: https://510kreport.com/device/K113755
Methodology: https://510kreport.com/methodology