510(k) · Cleared
ClearedFORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · PML Bone Cement, Posterior Screw Augmentation
Cleared on Mar 27, 2018 as substantially equivalent to K152604 (Medtronic Sofamor Danek USA, Incorporated, 2016) and 5 other predicates after a 242-day review. Its family tree reaches back 14 generations to 2004. 4 later devices descend from it.
- Decided
- Mar 27, 2018
- Review
- 242 days
- Class
- Class II
- Product code
- PML
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 14 generations to K040583 (2004). 108 ancestors in all, the oldest K841189 (1984). 4 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 10 generations between
- 3 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 2 generations backK152604 KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated · 2016
- 1 generation backK160879 CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM®…Medos International Sàrl · 2016
- This deviceK172269 FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™)…Globus Medical, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK181068 CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK253943 Tiger 2 SystemZavation Medical Products, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK253739 SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization…Globus Medical, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK213196 MARVEL™ Growing RodsGlobus Medical, Inc. · 2022
Show all 14 generations
- Root · 14 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 12 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 11 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 10 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 9 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 8 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 7 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 6 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 5 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 4 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 3 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 2 generations backK152604 KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated · 2016
- 1 generation backK160879 CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM®…Medos International Sàrl · 2016
- This deviceK172269 FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™)…Globus Medical, Inc. · 2018
Most influential descendants
Showing 4 of 4 · See all- K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc. · 2018 · cites it directly2descendants
- K253943Tiger 2 SystemZavation Medical Products, LLC · 2026 · cites it directly0descendants
- K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc. · 2026 · 2 generations on0descendants
- K213196MARVEL™ Growing RodsGlobus Medical, Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −13 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −12 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −11 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −10 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −9 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −8 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −7 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −6 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −5 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −4 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −3 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −2 | K152604 | KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set | Medtronic Sofamor Danek USA, Incorporated | 2016 | — |
| −1 | K160879 | CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated… | Medos International Sàrl | 2016 | — |
| 0 (this device) | K172269 | FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO®… | Globus Medical, Inc. | 2018 | — |
| +1 | K181068 | CREO® Stabilization System, REVERE® Stabilization System | Globus Medical, Inc. | 2018 | — |
| +1 | K253943 | Tiger 2 System | Zavation Medical Products, LLC | 2026 | — |
| +2 | K253739 | SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System… | Globus Medical, Inc. | 2026 | — |
| +2 | K213196 | MARVEL™ Growing Rods | Globus Medical, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 9 | 0 |
| 2002 | 5 | 0 |
| 2003 | 9 | 0 |
| 2004 | 20 | 0 |
| 2005 | 12 | 0 |
| 2006 | 7 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PML? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PML device
- #1 K200596 G21 Cement, VADER® Pedicle Systemscore 24.9 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K152604 | KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetSummary page 6…Regulatory Class II, Panel Code 87. Primary Medtronic KYPHON HV-R® Fenestrated Screw Cement and Predicate: CD HORIZON® Fenestrated Screw Set (K152604) Additional Predicates: FORTRESS™ Radiopaque Bone Cement (K042168) FORTRESS-Plus™ Radiopaque Bone Ceme… | 2016 |
| * | K042168 | CONCORD Radiopaque Bone CementSummary page 6…PHON HV-R® Fenestrated Screw Cement and Predicate: CD HORIZON® Fenestrated Screw Set (K152604) Additional Predicates: FORTRESS™ Radiopaque Bone Cement (K042168) FORTRESS-Plus™ Radiopaque Bone Cement (K162618) CONFIDENCE™ High Viscosity Spinal Cement,… | 2005 |
| * | K162618 | CONCORD Plus Radiopaque Bone CementSummary page 6…IZON® Fenestrated Screw Set (K152604) Additional Predicates: FORTRESS™ Radiopaque Bone Cement (K042168) FORTRESS-Plus™ Radiopaque Bone Cement (K162618) CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems… | 2017 |
| * | K160879 | CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsSummary page 6…-Plus™ Radiopaque Bone Cement (K162618) CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems (K160879) REVLOK® Fenestrated Screw System (K110280) Medtronic KYPHON Xpede Bone Cement and CD HORIZ… | 2016 |
| * | K110280 | Revlok Fenestrated Screw SystemSummary page 6…FIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems (K160879) REVLOK® Fenestrated Screw System (K110280) Medtronic KYPHON Xpede Bone Cement and CD HORIZON Fenestrated Screw Set (K171938) === P… | 2011 |
| * | K171938 | KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set Cleared while this submission was under review Summary page 6…REVLOK® Fenestrated Screw System (K110280) Medtronic KYPHON Xpede Bone Cement and CD HORIZON Fenestrated Screw Set (K171938) K172269 - Page 2 of 5 Purpose: The purpose… | 2017 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 6 companies; a new generation was cleared every 5 months on median.
- 18 of the 108 ancestors have a recall of any class.
- Of its descendants, K181068 (Globus Medical, Inc., 2018) has gone furthest, with 2 descendants of its own.
- 12 other devices also cite its predicate K152604.
How does its category compare?
All PML devicesPML Bone Cement, Posterior Screw Augmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · PML
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PML
116in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PML
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PML
55in 2025
MAUDE reports naming product code PML, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 2 | — | 0 | 34 |
| 2019 | 2 | — | 0 | 35 |
| 2020 | 3 | 182 | 0 | 27 |
| 2021 | 1 | — | 0 | 32 |
| 2022 | 2 | — | 0 | 12 |
| 2023 | 3 | 116 | 2 | 18 |
| 2024 | 1 | — | 0 | 60 |
| 2025 | 0 | — | 0 | 55 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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™…
Read the full statement (761 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172269 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172269: FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172269
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026