# K160216: Revolution Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Intelligent Implant Systems, LLC
- Decided: Apr 22, 2016 after 84 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: 2 generations back to K013196 (2002). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061364: Pilot Posterior Lumbar Plating System, Life Spine (2006) Summary page 4.
- K142939: Revolution Spinal Fixation System, Intelligent Implant Systems, LLC (2015) Summary page 4.
- K023415: Modification to Dynalok Classic Spinal System, Medtronic Sofamor Danek (2002) Summary page 4.
- K013196: Ascend Spinal Fixation System with the Shadow Spinal System, Spinal Innovations, LLC (2002) Summary page 4.

## Most influential descendants
- K163056: Revolution™ Spinal Fixation System (2017), 0 descendants of its own

## Indications for use
The Revolution™ Spinal Fixation System is intended for pedicle screw fixation of the non-cervical, posterior spine in order 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 the thoracic, lumbar, and sacral spine: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) spondylolisthesis, (3) trauma (i.e., fracture or dislocation), (4) spinal stenosis, (5) deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), (6) tumor, (7) pseudoarthrosis, (8) failed previous fusion.

Source page: https://510kreport.com/device/K160216
Methodology: https://510kreport.com/methodology