# K111449: Revolve Additional Implants

- Pathway: 510(k) (Special)
- Applicant: Globus Medical, Inc.
- Decided: Aug 17, 2011 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: 9 generations back to K990745 (1999). 38 ancestors in all.
236 later devices descend from it; 3 cite it directly.
1 of 275 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.
- K081195: Revere Uniplanar Screws, Globus Medical, Inc. (2008) Summary page 1.
- K091782: Revere 6.35 Stabilization System, Globus Medical, Inc. (2009) Summary page 1.
- K093294: Revere Stabilization System, Globus Medical, Inc. (2010) Summary page 1.
- K100788: Cocr Rods, Globus Medical, Inc. (2010) Summary page 1.
- K083416: Revolve Stabilization System, Globus Medical, Inc. (2009) Summary page 1.

## Most influential descendants
- 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
- K150552: ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS (2015), 96 descendants of its own

## Indications for use
The REVOLVE® Stabilization System, when used as a posterior pedlicle 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, pseudloarthrosis and failed previous fusion. In addition, the REVOLVE® 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/K111449
Methodology: https://510kreport.com/methodology