# K113395: Revere 4.5 Stabilization System

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Jun 14, 2012 after 210 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: 10 generations back to K040583 (2004). 108 ancestors in all.
260 later devices descend from it; 10 cite it directly.
1 of 369 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.
- K091782: Revere 6.35 Stabilization System, Globus Medical, Inc. (2009) Summary page 1.
- K100788: Cocr Rods, Globus Medical, Inc. (2010) Summary page 1.
- K091445: CD Horizon Spinal System, Medtronic Sofamor Danek (2010) Summary page 1.
- K102807: CD Horizon Spinal System, Medtronic Sofamor Danek, Inc. (2010) Summary page 1.
- K994121: Small Stature Uss, Synthes (Usa) (2000) Summary page 1.
- K103287: Synthes 6.0 Cocr and CPT TI-3 Rods, Synthes Spine (2011) 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 REVERE® 4.5 Stabilization System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients (including small stature) and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann’s Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis). When used for posterior non-cervical pedicle screw fixation in pediatric patients, the REVERE® 4.5 Stabilization System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The REVERE® 4.5 Stabilization System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. In order to achieve additional levels of fixation in skeletally mature patients, the REVERE® 4.5 Stabilization System rods may be connected to the REVERE® Stabilization System (5.5mm or 6.35mm rod) or ELLIPSE® Occipito-Cervico-Thoracic Spinal System (3.5mm rod) using corresponding connectors. Refer to the REVERE® or ELLIPSE® system package insert for instructions and indications of use.

Source page: https://510kreport.com/device/K113395
Methodology: https://510kreport.com/methodology