# K133350: Revere Stabilization System

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Mar 11, 2014 after 132 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: 14 generations back to K853033 (1985). 201 ancestors in all.
93 later devices descend from it; 7 cite it directly.
1 of 295 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.
- K122226: Revere Stabilization System, Globus Medical, Inc. (2012) Summary page 1.
- K984251: Xia Spine System, Howmedica, Inc. (1999) Summary page 1.
- K113666: Xia 3 Spinal System, Stryker Spine (2012) Summary page 1.
- K961633: CD Horizon Spinal System, Sofamor Danek USA,Inc. (1996) Summary page 1.
- K130646: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2013) Summary page 1.
- K982987: Synthes Posterior Universal Spinal System, Synthes Spine (1998) Summary page 1.

## Most influential descendants
- K171651: Excelsius GPS (2017), 69 descendants of its own
- K191100: ExcelsiusGPS Spine 1.1 Interbody Module (2019), 42 descendants of its own
- K222270: HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments (2022), 23 descendants of its own
- K141222: Nautilus Spinal System and Solstice Oct System (2015), 13 descendants of its own
- K151196: Nautilus Spinal System (2015), 12 descendants of its own

## Indications for use
The REVER* 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? 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-sacrurn/ilium. When used as a posterior non-pedicle screw fixation system, the REVEREO 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 TI-sacrumilium. When used as an anterolateral thoracolumbar system, the REVERE 0 Stabilization System is intended for anterolateral screw (with or without staples or staple plates) 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-LS.

Source page: https://510kreport.com/device/K133350
Methodology: https://510kreport.com/methodology