# K083416: Revolve Stabilization System

- Pathway: 510(k) (Special)
- Applicant: Globus Medical, Inc.
- Decided: Jan 9, 2009 after 52 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: 5 generations back to K990745 (1999). 12 ancestors in all.
297 later devices descend from it; 3 cite it directly.
1 of 310 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061202: Revere Stabilization System, Globus Medical, Inc. (2006) Summary page 1.

## Most influential descendants
- K111449: Revolve Additional Implants (2011), 236 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 REVOLVE TM Stabilization System, when used as a posterior pedicle screw 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 the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion. In addition, the REVOLVE TM Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants-after-attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

Source page: https://510kreport.com/device/K083416
Methodology: https://510kreport.com/methodology