510(k) · Cleared
ClearedRevere Stabilization 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 Mar 11, 2014 as substantially equivalent to K061202 (Globus Medical, Inc., 2006) and 6 other predicates after a 132-day review. Its family tree reaches back 14 generations to 1985. 1 of the 295 devices in its family, counting itself, has a Class I recall. 93 later devices descend from it.
- Decided
- Mar 11, 2014
- Review
- 132 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 14 generations to K853033 (1985). 201 ancestors in all, the oldest K781443 (1978). 93 later devices descend from it, 7 citing it directly. 1 of the 295 devices in this family, counting this one, has a Class I recall.
- Root · 14 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 10 generations between
- 3 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 2 generations backK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
- 1 generation backK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
- This deviceK133350 Revere Stabilization SystemGlobus Medical, Inc. · 2014
- Descendant · cites it directly · 69 of its ownK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 42 of its ownK191100 ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019
- Descendant · 3 generations on · 23 of its ownK222270 HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable…Globus Medical, Inc. · 2022
- Descendant · cites it directly · 13 of its ownK141222 Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc. · 2015
- Descendant · 2 generations on · 12 of its ownK151196 Nautilus Spinal SystemLife Spine, Inc. · 2015
Show all 14 generations
- Root · 14 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 13 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 12 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 11 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 10 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 9 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 8 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 7 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 6 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 5 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 4 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 3 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 2 generations backK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
- 1 generation backK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
- This deviceK133350 Revere Stabilization SystemGlobus Medical, Inc. · 2014
Showing 5 of 93 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub2 generations on · 2021
Most influential descendants
Showing 5 of 93 · See all- K171651Excelsius GPSGlobus Medical, Inc. · 2017 · cites it directly69descendants
- K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019 · 2 generations on42descendants
- K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc. · 2022 · 3 generations on23descendants
- K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc. · 2015 · cites it directly13descendants
- K151196Nautilus Spinal SystemLife Spine, Inc. · 2015 · 2 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −13 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −12 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −11 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −10 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −9 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −8 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −7 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −6 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −5 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −4 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −3 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −2 | K101070 | Expedium Spine System | Medos International SARL | 2010 | 1 |
| −1 | K122226 | Revere Stabilization System | Globus Medical, Inc. | 2012 | — |
| 0 (this device) | K133350 | Revere Stabilization System | Globus Medical, Inc. | 2014 | — |
| +1 | K171651 | Excelsius GPS | Globus Medical, Inc. | 2017 | 1 |
| +2 | K191100 | ExcelsiusGPS Spine 1.1 Interbody Module | Globus Medical, Inc. | 2019 | — |
| +3 | K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer… | Globus Medical, Inc. | 2022 | — |
| +1 | K141222 | Nautilus Spinal System and Solstice Oct System | Life Spine, Inc. | 2015 | — |
| +2 | K151196 | Nautilus Spinal System | Life Spine, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 6 | 0 |
| 1997 | 4 | 0 |
| 1998 | 8 | 0 |
| 1999 | 9 | 0 |
| 2000 | 11 | 0 |
| 2001 | 18 | 0 |
| 2002 | 8 | 0 |
| 2003 | 11 | 0 |
| 2004 | 23 | 0 |
| 2005 | 21 | 0 |
| 2006 | 11 | 0 |
| 2007 | 9 | 0 |
| 2008 | 11 | 0 |
| 2009 | 11 | 0 |
| 2010 | 7 | 0 |
| 2011 | 8 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 6 | 1 |
| 2022 | 8 | 0 |
| 2023 | 11 | 0 |
| 2024 | 20 | 0 |
| 2025 | 15 | 0 |
| 2026 | 20 | 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? (7)
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…stem Product Codes MNH, MNI, NKB, KWP, KWQ Regulatory Class Ill, Panel Code 87. Predicate(s): REVERE® Stabilization System (K061 202, K1 22226) Stryker XIA® Spine System (K984251, K1 13666) Medtronic CID HORIZON® (K961633,… | 2006 |
| * | K122226 | Revere Stabilization SystemSummary page 1…Product Codes MNH, MNI, NKB, KWP, KWQ Regulatory Class Ill, Panel Code 87. Predicate(s): REVERE® Stabilization System (K061 202, K1 22226) Stryker XIA® Spine System (K984251, K1 13666) Medtronic CID HORIZON® (K961633, K1 30646)… | 2012 |
| * | K984251 | Xia Spine SystemSummary page 1…Regulatory Class Ill, Panel Code 87. Predicate(s): REVERE® Stabilization System (K061 202, K1 22226) Stryker XIA® Spine System (K984251, K1 13666) Medtronic CID HORIZON® (K961633, K1 30646) Synthes Posterior Universal Spine S… | 1999 |
| * | K113666 | Xia 3 Spinal SystemSummary page 1…Regulatory Class Ill, Panel Code 87. Predicate(s): REVERE® Stabilization System (K061 202, K1 22226) Stryker XIA® Spine System (K984251, K1 13666) Medtronic CID HORIZON® (K961633, K1 30646) Synthes Posterior Universal Spine System (K98… | 2012 |
| * | K961633 | CD Horizon Spinal SystemSummary page 1…s): REVERE® Stabilization System (K061 202, K1 22226) Stryker XIA® Spine System (K984251, K1 13666) Medtronic CID HORIZON® (K961633, K1 30646) Synthes Posterior Universal Spine System (K982987) Purpose: The purpose of this submission is to r… | 1996 |
| * | K130646 | CD Horizon Spinal SystemSummary page 1…REVERE® Stabilization System (K061 202, K1 22226) Stryker XIA® Spine System (K984251, K1 13666) Medtronic CID HORIZON® (K961633, K1 30646) Synthes Posterior Universal Spine System (K982987) Purpose: The purpose of this submission is to request cle… | 2013 |
| * | K982987 | Synthes Posterior Universal Spinal SystemSummary page 1…tryker XIA® Spine System (K984251, K1 13666) Medtronic CID HORIZON® (K961633, K1 30646) Synthes Posterior Universal Spine System (K982987) Purpose: The purpose of this submission is to request clearance for additional threaded screws with a threaded locking cap and c… | 1998 |
What descends from it? (93)
See all 937 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171651 | Excelsius GPS | 2017 | 69 |
| K141222 | Nautilus Spinal System and Solstice Oct System | 2015 | 13 |
| K232341 | CarboClear® Pedicle Screw System | 2023 | 4 |
| K181068 | CREO® Stabilization System, REVERE® Stabilization System | 2018 | 2 |
| K253739 | SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5… | 2026 | 0 |
| K232586 | Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System | 2023 | 0 |
| K200937 | ACURA Stabilization System | 2020 | 0 |
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 · 2 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 29 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 19 of the 201 ancestors have a recall of any class.
- Of its descendants, K171651 (Globus Medical, Inc., 2017) has gone furthest, with 69 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. 2014, 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 REVER* 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 (291 words)
The REVER* 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-sacrurn/ilium.
When used as a posterior non-pedicle screw fixation system, the REVEREO 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 TI-sacrumilium.
When used as an anterolateral thoracolumbar system, the REVERE 0 Stabilization System is intended for anterolateral screw (with or without staples or staple plates) 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-LS.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133350 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133350: Revere Stabilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133350
Report an extraction error
Are you the manufacturer?
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