510(k) · Decided
DecidedRevlok Fenestrated Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jul 6, 2011 as substantially equivalent to K061202 (Globus Medical, Inc., 2006) and 4 other predicates after a 156-day review. Its family tree reaches back 7 generations to 1999. 95 later devices descend from it.
- Decided
- Jul 6, 2011
- Review
- 156 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K990745 (1999). 19 ancestors in all, the oldest K955348 (1996). 95 later devices descend from it, 7 citing it directly.
- Root · 7 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 6 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 5 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 4 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 3 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 2 generations backK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
- 1 generation backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
- This deviceK110280 Revlok Fenestrated Screw SystemGlobus Medical, Inc. · 2011
- Descendant · cites it directly · 67 of its ownK160989 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
- Descendant · 2 generations on · 41 of its ownK180498 NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated · 2018
- Descendant · 2 generations on · 39 of its ownK170126 NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated · 2017
- Descendant · 3 generations on · 28 of its ownK190526 High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd. · 2019
- Descendant · 4 generations on · 27 of its ownK200596 G21 Cement, VADER® Pedicle SystemIcotec AG · 2020 · Recalled
Showing 5 of 95 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 95 · See all- K160989NuVasive® Reline® SystemNu Vasive, Incorporated · 2016 · cites it directly67descendants
- K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated · 2018 · 2 generations on41descendants
- K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated · 2017 · 2 generations on39descendants
- K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd. · 2019 · 3 generations on28descendants
- K200596G21 Cement, VADER® Pedicle SystemIcotec AG · 2020 · 4 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −6 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −5 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −4 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −3 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −2 | K081195 | Revere Uniplanar Screws | Globus Medical, Inc. | 2008 | — |
| −1 | K091782 | Revere 6.35 Stabilization System | Globus Medical, Inc. | 2009 | — |
| 0 (this device) | K110280 | Revlok Fenestrated Screw System | Globus Medical, Inc. | 2011 | — |
| +1 | K160989 | NuVasive® Reline® System | Nu Vasive, Incorporated | 2016 | — |
| +2 | K180498 | NuVasive Reline Fenestrated Screws, High V+ Bone Cement | Nu Vasive, Incorporated | 2018 | — |
| +2 | K170126 | NuVasive® Reline® 4.5-5.0 System | Nu Vasive, Incorporated | 2017 | — |
| +3 | K190526 | High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws | CarboFix Orthopedics, Ltd. | 2019 | — |
| +4 | K200596 | G21 Cement, VADER® Pedicle System | Icotec AG | 2020 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2019 | 6 | 0 |
| 2020 | 7 | 0 |
| 2021 | 6 | 0 |
| 2022 | 6 | 0 |
| 2023 | 17 | 0 |
| 2024 | 15 | 0 |
| 2025 | 11 | 0 |
| 2026 | 15 | 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 NKB? 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 NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K061202 | Revere Stabilization SystemSummary page 1…Product Codes MNH, MNI, KWQ, NKB. Regulatory Class 11and Ill, Panel Code 87. Predicate(s): Globus Medical REVERE® Stabilization System (K061 202, K081195 and K091782); and REVOLVE® Stabilization System (K083416) and Theken Spine CoraI… | 2006 |
| * | K081195 | Revere Uniplanar ScrewsSummary page 1…KWQ, NKB. Regulatory Class 11and Ill, Panel Code 87. Predicate(s): Globus Medical REVERE® Stabilization System (K061 202, K081195 and K091782); and REVOLVE® Stabilization System (K083416) and Theken Spine CoraITM Spinal… | 2008 |
| * | K091782 | Revere 6.35 Stabilization SystemSummary page 1…Regulatory Class 11and Ill, Panel Code 87. Predicate(s): Globus Medical REVERE® Stabilization System (K061 202, K081195 and K091782); and REVOLVE® Stabilization System (K083416) and Theken Spine CoraITM Spinal System (K07… | 2009 |
| * | K083416 | Revolve Stabilization SystemSummary page 1…edicate(s): Globus Medical REVERE® Stabilization System (K061 202, K081195 and K091782); and REVOLVE® Stabilization System (K083416) and Theken Spine CoraITM Spinal System (K070962). Purpose: The purpose of this submission is clearance of th… | 2009 |
| * | K070962 | Coral Pedicle Screw SystemSummary page 1…02, K081195 and K091782); and REVOLVE® Stabilization System (K083416) and Theken Spine CoraITM Spinal System (K070962). Purpose: The purpose of this submission is clearance of the REVLOK TM Fenestrated Screw System, a modification of the cleared R… | 2007 |
What descends from it? (95)
See all 957 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160989 | NuVasive® Reline® System | 2016 | 67 |
| K123717 | Ucentum | 2013 | 17 |
| K223273 | ASTRA Spine System | 2022 | 8 |
| K172269 | FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw… | 2018 | 4 |
| K151704 | Diplomat® Spinal System | 2016 | 4 |
| K200937 | ACURA Stabilization System | 2020 | 0 |
| K200981 | Mega Plus MIS Spine System | 2020 | 0 |
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 12 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 19 ancestors have a recall of any class.
- Of its descendants, K160989 (Nu Vasive, Incorporated, 2016) has gone furthest, with 67 descendants of its own.
- 29 other devices also cite its predicate K061202.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The REVLOKTM 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…
Read the full statement (227 words)
The REVLOKTM 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, pseudloarthrosis and failed previous fusion.
In addition, the REVLOK TM 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 REVLOKTM 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 lordlosis), fracture or dislocation of the thoracolumbar spine, pseudloarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L-5.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110280 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110280: 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/K110280
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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