510(k) · Cleared
ClearedRevere Uniplanar Screws
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 May 28, 2008 as substantially equivalent to K061202 (Globus Medical, Inc., 2006) after a 30-day review. Its family tree reaches back 5 generations to 1999. 1 of the 418 devices in its family, counting itself, has a Class I recall. 405 later devices descend from it.
- Decided
- May 28, 2008
- Review
- 30 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K990745 (1999). 12 ancestors in all, the oldest K962628 (1997). 405 later devices descend from it, 7 citing it directly. 1 of the 418 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 4 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 3 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 2 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 1 generation backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- This deviceK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
- Descendant · cites it directly · 404 of its ownK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
- Descendant · cites it directly · 376 of its ownK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- Descendant · cites it directly · 374 of its ownK100788 Cocr RodsGlobus Medical, Inc. · 2010
- Descendant · 2 generations on · 260 of its ownK113395 Revere 4.5 Stabilization SystemGlobus Medical, Inc. · 2012
- Descendant · cites it directly · 236 of its ownK111449 Revolve Additional ImplantsGlobus Medical, Inc. · 2011
Showing 5 of 405 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub3 generations on · 2021
Most influential descendants
Showing 5 of 405 · See all- K091782Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009 · cites it directly404descendants
- K093294Revere Stabilization SystemGlobus Medical, Inc. · 2010 · cites it directly376descendants
- K100788Cocr RodsGlobus Medical, Inc. · 2010 · cites it directly374descendants
- K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc. · 2012 · 2 generations on260descendants
- K111449Revolve Additional ImplantsGlobus Medical, Inc. · 2011 · cites it directly236descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −4 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −3 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −2 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −1 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| 0 (this device) | K081195 | Revere Uniplanar Screws | Globus Medical, Inc. | 2008 | — |
| +1 | K091782 | Revere 6.35 Stabilization System | Globus Medical, Inc. | 2009 | — |
| +1 | K093294 | Revere Stabilization System | Globus Medical, Inc. | 2010 | — |
| +1 | K100788 | Cocr Rods | Globus Medical, Inc. | 2010 | — |
| +2 | K113395 | Revere 4.5 Stabilization System | Globus Medical, Inc. | 2012 | — |
| +1 | K111449 | Revolve Additional Implants | Globus Medical, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 3 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 7 | 0 |
| 2012 | 8 | 0 |
| 2013 | 12 | 0 |
| 2014 | 11 | 0 |
| 2015 | 20 | 0 |
| 2016 | 14 | 0 |
| 2017 | 27 | 0 |
| 2018 | 30 | 0 |
| 2019 | 21 | 0 |
| 2020 | 28 | 0 |
| 2021 | 21 | 1 |
| 2022 | 28 | 0 |
| 2023 | 44 | 0 |
| 2024 | 48 | 0 |
| 2025 | 42 | 0 |
| 2026 | 40 | 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.
1 device in this family has a Class I recall. 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? (1)
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…MNH, MNI, KWQ, KWP, NKB. Regulatory Class IIand Ill, Panel Code 87. Predicate(s): Globus Medical REVERE TM Stabilization System K061202, SE date July 20, 2006 Device Description: The REVERETM Stabilization System consists of rods, hooks, monoaxial screws, uniplana… | 2006 |
What descends from it? (405)
See all 4057 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091782 | Revere 6.35 Stabilization System | 2009 | 404 |
| K093294 | Revere Stabilization System | 2010 | 376 |
| K100788 | Cocr Rods | 2010 | 374 |
| K111449 | Revolve Additional Implants | 2011 | 236 |
| K122226 | Revere Stabilization System | 2012 | 225 |
| K110280 | Revlok Fenestrated Screw System | 2011 | 95 |
| K121670 | Medyssey Cannulated Pedicle Screw | 2013 | 11 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K091782 (Globus Medical, Inc., 2009) has gone furthest, with 404 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. 2008, 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 REVERE Stabilization 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…
Read the full statement (287 words)
The REVERE Stabilization 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 REVERE 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 as a posterior non-pedicle screw fixation system, the REVERE Stabilization System is intended for the treatment of 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, Scheuermann's disease), fracture, pseudarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are T1-sacrum/ilium.
When used as an anterolateral thoracolumbar system, the REVERE Stabilization 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081195 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081195: Revere Uniplanar Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081195
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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