# K061202: Revere Stabilization System

- Pathway: 510(k) (Special)
- Applicant: Globus Medical, Inc.
- Decided: Jul 20, 2006 after 80 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: 4 generations back to K990745 (1999). 11 ancestors in all.
547 later devices descend from it; 30 cite it directly.
1 of 559 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040442: Protex Stabilization System, Globus Medical, Inc. (2004) Summary page 1.
- K052069: Protex Stabilization System with Additional Componentes, Globus Medical, Inc. (2005) Summary page 1.
- K012870: Xia Stainless Steel System, Howmedica Osteonics Corp. (2001) Summary page 1.
- K031090: Modification to Xia Stainless Steel System, Howmedica Osteonics Corp. (2003) Summary page 1.
- K053115: Xia Spinal System, Stryker Spine (2005) Summary page 1.

## Most influential descendants
- K081195: Revere Uniplanar Screws (2008), 405 descendants of its own
- K091782: Revere 6.35 Stabilization System (2009), 404 descendants of its own
- K093294: Revere Stabilization System (2010), 376 descendants of its own
- K073172: Beacon Stabilization System (2007), 376 descendants of its own
- K092610: Modification to Beacon Stabilization System (2009), 375 descendants of its own

## Indications for use
The REVERE 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 REVERE 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. When used as a posterior non-pedicle screw fixation system, the REVERE TM Stabilization System is intended for the treatment of 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 lordosis, Scheuermann's disease), fracture, pseudarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are Tl-sacrum/ilium. When used as an anterolateral thoracolumbar system, the REVERE Stabilization 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 lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.

Source page: https://510kreport.com/device/K061202
Methodology: https://510kreport.com/methodology