# K984350: VSP System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Motech Acromed
- Decided: Jan 20, 1999 after 47 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
No predicates in its family tree.
308 later devices descend from it; 6 cite it directly.
1 of 309 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) VSP System: named in the summary without a submission number

## Most influential descendants
- K101070: Expedium Spine System (2010), 260 descendants of its own
- K122226: Revere Stabilization System (2012), 225 descendants of its own
- K124058: Creo Stabilization System (2013), 172 descendants of its own
- K143633: CREO Stabilization System (2015), 158 descendants of its own
- K123783: Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol Implants (2013), 97 descendants of its own

## Indications for use
The VSP System is indicated for degenerative spondylolisthesis, in skeletally mature N patients, with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). Levels of fixation are for the thoracic, limbar and sacral spine. The VSP Systern is also indicated for pedicle screw fixation for severe spondylolisthesis (Grades 3 and 4) at LS-31, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.

Source page: https://510kreport.com/device/K984350
Methodology: https://510kreport.com/methodology