# K152920: Savannah-T® Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Amendia, Inc.
- Decided: Jul 8, 2016 after 280 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K955348 (1996). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132925: Savannah-T, Reduction, Savannah-T, High-Top, Savannah-T, Monoaxial Mid-Top, Savannah-T, Low-Top, Savannah-Link, Amendia, Inc. (2014) Summary page 4.
- K102995: Talon Spinal System, Spine360 (2011) Summary page 4.

## Recalls of this device
- Nov 22, 2016 · Class II · Z-0883-2017: The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.

## Indications for use
The Savannah-T® Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and/or sacral spine, specifically as follows: * When intended for pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients the Savannah- T® is indicated for one or more of the following: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and/or failed previous fusion (pseudarthrosis). * In addition, when used as a pedicle screw fixation system, the Savannah-T® is indicated for skeletally mature patients having degenerative spondylolisthesis with objective evidence of neurologic impairment and/or severe spondylolisthesis (grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; who are receiving fusions using autogenous bone graft only; who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and who are having the device removed after the development of a solid fusion mass.

Source page: https://510kreport.com/device/K152920
Methodology: https://510kreport.com/methodology