# K172269: FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System - Pathway: 510(k) (Traditional) - Applicant: Globus Medical, Inc. - Decided: Mar 27, 2018 after 242 days - Product code: PML (Bone Cement, Posterior Screw Augmentation) - Device class: 2 - Regulation: 21 CFR 888.3027 - 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 K040583 (2004). 108 ancestors in all. 4 later devices descend from it; 2 cite it directly. 0 of 113 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K152604: KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set, Medtronic Sofamor Danek USA, Incorporated (2016) Summary page 6. - K042168: CONCORD Radiopaque Bone Cement, Globus Medical, Inc. (2005) Summary page 6. - K162618: CONCORD Plus Radiopaque Bone Cement, Globus Medical, Inc. (2017) Summary page 6. - K160879: CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems, Medos International Sàrl (2016) Summary page 6. - K110280: Revlok Fenestrated Screw System, Globus Medical, Inc. (2011) Summary page 6. - K171938: KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set, Medtronic (2017). Cleared while this submission was under review Summary page 6. ## Most influential descendants - K181068: CREO® Stabilization System, REVERE® Stabilization System (2018), 2 descendants of its own - K253943: Tiger 2 System (2026), 0 descendants of its own - K253739: SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System (2026), 0 descendants of its own - K213196: MARVEL™ Growing Rods (2022), 0 descendants of its own ## Indications for use FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™) is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma). When used in conjunction with CREO® or REVLOK® Fenestrated Screw Systems for posterior fixation, FORTRESS™ Radiopaque Bone Cement 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. FORTRESS™ Radiopaque Bone Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised. CREO® Fenestrated Screw 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 CREO® Fenestrated Screw 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 an anterolateral thoracolumbar system, the CREO® Fenestrated Screw 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. 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™ or FORTRESS-Plus™ bone cement are intended for use at spinal levels where the structural integrity of the spine is not severely compromised. REVLOK® Fenestrated Screw 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 REVLOK® Fenestrated Screw 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 an anterolateral thoracolumbar system, the REVLOK® Fenestrated Screw 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. When used for posterior fixation in conjunction with FORTRESS™ or FORTRESS-Plus™ bone cement, the REVLOK® 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. REVLOK® Fenestrated screws augmented with FORTRESS™ or FORTRESS-Plus™ bone cement are intended for use at spinal levels where the structural integrity of the spine is not severely compromised. Source page: https://510kreport.com/device/K172269 Methodology: https://510kreport.com/methodology