# K110280: Revlok Fenestrated Screw System

- Pathway: 510(k) (Special)
- Applicant: Globus Medical, Inc.
- Decided: Jul 6, 2011 after 156 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: 7 generations back to K990745 (1999). 19 ancestors in all.
95 later devices descend from it; 7 cite it directly.
0 of 115 devices in its family (counting itself) have 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.
- K083416: Revolve Stabilization System, Globus Medical, Inc. (2009) Summary page 1.
- K070962: Coral Pedicle Screw System, Theken Spine, LLC (2007) Summary page 1.

## Most influential descendants
- K160989: NuVasive® Reline® System (2016), 67 descendants of its own
- K180498: NuVasive Reline Fenestrated Screws, High V+ Bone Cement (2018), 41 descendants of its own
- K170126: NuVasive® Reline® 4.5-5.0 System (2017), 39 descendants of its own
- K190526: High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws (2019), 28 descendants of its own
- K200596: G21 Cement, VADER® Pedicle System (2020), 27 descendants of its own

## Indications for use
The REVLOKTM Fenestrated Screw 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, pseudloarthrosis and failed previous fusion. In addition, the REVLOK TM Fenestrated Screw 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. When used as an anterolateral thoracolumbar system, the REVLOKTM Fenestrated Screw System is intended for anterolateral screw (with or without staple) fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordlosis), fracture or dislocation of the thoracolumbar spine, pseudloarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L-5.

Source page: https://510kreport.com/device/K110280
Methodology: https://510kreport.com/methodology