# K124058: Creo Stabilization System

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: May 13, 2013 after 133 days
- Product code: OSH (Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis)
- 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). 183 ancestors in all.
172 later devices descend from it; 15 cite it directly.
2 of 356 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122226: Revere Stabilization System, Globus Medical, Inc. (2012) Summary page 1.
- K113395: Revere 4.5 Stabilization System, Globus Medical, Inc. (2012) Summary page 1.
- K102807: CD Horizon Spinal System, Medtronic Sofamor Danek, Inc. (2010) Summary page 1.
- K031175: Click'x Monoaxial Screws and Hooks, Synthes (Usa) (2003) Summary page 1.
- K100952: Modification to Synthes Matrix System, Synthes Spine (2010) Summary page 1.
- K103287: Synthes 6.0 Cocr and CPT TI-3 Rods, Synthes Spine (2011) Summary page 1.
- K111136: Expedium Spine System, Viper System, Viper 2 System, Depuy Spine, Inc. (2012)

## Most influential descendants
- K143633: CREO Stabilization System (2015), 158 descendants of its own
- K180210: CREO® Stabilization System (2018), 88 descendants of its own
- K192938: Invictus™ Spinal Fixation System (2019), 69 descendants of its own
- K171651: Excelsius GPS (2017), 69 descendants of its own
- K203056: Invictus™ Spinal Fixation System (2020), 61 descendants of its own

## Indications for use
The CREO 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 for pediatric patients (CREO 4.75 only). 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 as an adjunct to fusion, the CREO Stabilization System is intended to be used with autograft and/or allograft. In addition, the CREO 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 for posterior non-cervical pedicle screw fixation in pediatric patients, the CREO 4.75 Stabilization System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The CREO 4.75 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 CREO Stabilization System rods may be connected to the REVERE® Stabilization System (5.5mm or 6.35mm rod), REVERE® 4.5 Stabilization System (4.5mm rod) or ELLIPSE® Occipito-Cervico-Thoracic Spinal System (3.5mm rod) using corresponding connectors. In order to achieve additional levels of fixation in pediatric patients, the CREO Stabilization System rods may be connected to the REVERE® 4.5 Stabilization System using corresponding connectors. Refer to the REVERE®, REVERE® 4.5, or ELLIPSE® system package insert for instructions and indications of use.

Source page: https://510kreport.com/device/K124058
Methodology: https://510kreport.com/methodology