# K072116: Savannah Lumbar Percutaneous Stabilization System

- Pathway: 510(k) (Traditional)
- Applicant: Neurospine Innovations and Solutions
- Decided: Mar 20, 2008 after 232 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- 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: 4 generations back to K955348 (1996). 19 ancestors in all.
24 later devices descend from it; 2 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022949: Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature Uss, Synthes (Usa) (2003) Summary page 2.
- K010108: Uss-Line Extension, Synthes (2001) Summary page 2.
- K010658: Modified Uss Fracture System, Synthes (Usa) (2001) Summary page 2.
- K994121: Small Stature Uss, Synthes (Usa) (2000) Summary page 2.
- K982987: Synthes Posterior Universal Spinal System, Synthes Spine (1998) Summary page 2.
- K022623: 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System), Depuyacromed (2002) Summary page 2.
- K983583: Depuy Acromed Moss and Moss Miami Spinal Systems, Depuy, Inc. (1998) Summary page 2.
- K964024: Depuy Motech Titanium Moss Miami Spinal System, Depuy, Inc. (1997) Summary page 2.
- K955348: Titanium Moss Miami Spinal System, Depuy, Inc. (1996) Summary page 2.
- K933881: Depuy Motech Moss-Miami Spinal System, Depuy, Inc. (1994) Summary page 2.
- K031585: U&I, Optima, Spinal System, U&I Corp., America (2003) Summary page 2.
- K001319: Xia Spine System Hooks, Howmedica Osteonics Corp. (2000)
- K984251: Xia Spine System, Howmedica, Inc. (1999) Summary page 2.
- K951725: Osteonics Spinal System, Osteonics Corp. (1995) Summary page 2.

## Most influential descendants
- K132925: Savannah-T, Reduction, Savannah-T, High-Top, Savannah-T, Monoaxial Mid-Top, Savannah-T, Low-Top, Savannah-Link (2014), 23 descendants of its own
- K192121: Black Diamond Pedicle Screw System (2019), 13 descendants of its own
- K213935: PISCES-SA Standalone ALIF Interbody System (2022), 12 descendants of its own
- K161842: Overwatch Spine System (2016), 6 descendants of its own
- K231199: Solar Lumbar Interbody Fusion System (2023), 5 descendants of its own

## Indications for use
The Savannah Lumbar Percutaneous Stabilization System (SLPSS) is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows: When used as a pedicle screw fixation system of the posterior lumbar spine in skeletally mature patients, the SLPSS is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) spinal tumor, and/or (5) failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the SLPSS is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S 1) vertebral 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 (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass. The Savannah Lumbar Percutaneous Stabilization System (SLPSS) is also intended to provide immobilization and stabilization of the spinal segments of the lumbar and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S I or degenerative spondylolisthesis with objective evidence of neurologic impairment.

Source page: https://510kreport.com/device/K072116
Methodology: https://510kreport.com/methodology