# K203153: CREO Stabilization System, Navigation Instruments, ExcelsiusGPS - Pathway: 510(k) (Traditional) - Applicant: Globus Medical, Inc. - Decided: Jan 19, 2021 after 89 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: 21 generations back to K040583 (2004). 694 ancestors in all. 1 later device descends from it; 1 cites it directly. 7 of 696 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K124058: Creo Stabilization System, Globus Medical, Inc. (2013) Summary page 7. - K143633: CREO Stabilization System, Globus Medical, Inc. (2015) Summary page 7. - K191835: CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments, Globus Medical, Inc. (2019) Summary page 7. - K153203: Navigation Instruments, Globus Medical, Inc. (2016) Summary page 7. - K180690: Navigation Instruments, Globus Medical, Inc. (2018) Summary page 7. - K171651: Excelsius GPS, Globus Medical, Inc. (2017) Summary page 7. - K200047: ExcelsiusGPS Cranial 1.0 Module, Globus Medical, Inc. (2020) Summary page 7. ## Most influential descendants - K253739: SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System (2026), 0 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. These devices are indicated as an adjunct to fusion for 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® Stabilization System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The CREO® 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, the CREO® Stabilization System rods may be connected to the REVERE Stabilization System (4.5mm, 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. In-Line Connector Growing Rods are indicated in patients under 10 years of age with potential for additional spine growth who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early onset spinal deformities associated with thoracic insufficiency, including early onset scoliosis, as part of a growing rod construct. Globus Navigation Instruments are intended to be used during the preparation and placement of CREO® screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. When used for posterior fixation in conjunction with FORTRESS™ or FORTRESS-Plus™ bone cement, the CREO® Fenestrated Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CREO® Fenestrated screws augmented with FORTRESS™ and FORTRESS-Plus™ bone cements are for use at spinal levels where the structural integrity of the spine is not severely compromised. Globus Navigation Instruments are intended to be used during the preparation and placement of Globus screws (QUARTEX®, CREO®, REVERE®, REVOLVE®, ELLIPSE®, PROTEX® CT, and SI-LOK®) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy. The ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody spacers, and intracranial devices such as biopsy needles, electrodes, and tubes. Source page: https://510kreport.com/device/K203153 Methodology: https://510kreport.com/methodology