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 Oct 1, 2012 as substantially equivalent to K061202 (Globus Medical, Inc., 2006) and 8 other predicates after a 67-day review. Its family tree reaches back 13 generations to 1985. 1 of the 402 devices in its family, counting itself, has a Class I recall. 225 later devices descend from it.
- Decided
- Oct 1, 2012
- Review
- 67 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 13 generations to K853033 (1985). 176 ancestors in all, the oldest K781443 (1978). 225 later devices descend from it, 8 citing it directly. 1 of the 402 devices in this family, counting this one, has a Class I recall.
- Root · 13 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 9 generations between
- 3 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 2 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 1 generation backK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
- This deviceK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
- Descendant · cites it directly · 172 of its ownK124058 Creo Stabilization SystemGlobus Medical, Inc. · 2013
- Descendant · 2 generations on · 158 of its ownK143633 CREO Stabilization SystemGlobus Medical, Inc. · 2015
- Descendant · cites it directly · 97 of its ownK123783 Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc. · 2013
- Descendant · 2 generations on · 96 of its ownK150552 ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc. · 2015 · Recalled
- Descendant · cites it directly · 93 of its ownK133350 Revere Stabilization SystemGlobus Medical, Inc. · 2014
Show all 13 generations
- Root · 13 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 12 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 11 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 10 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 9 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 8 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 7 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 6 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 5 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 4 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 3 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 2 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 1 generation backK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
- This deviceK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
Showing 5 of 225 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 225 · See all- K124058Creo Stabilization SystemGlobus Medical, Inc. · 2013 · cites it directly172descendants
- K143633CREO Stabilization SystemGlobus Medical, Inc. · 2015 · 2 generations on158descendants
- K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc. · 2013 · cites it directly97descendants
- K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc. · 2015 · 2 generations on96descendants
- K133350Revere Stabilization SystemGlobus Medical, Inc. · 2014 · cites it directly93descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −12 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −11 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −10 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −9 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −8 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −7 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −6 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −5 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −4 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −3 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −2 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −1 | K101070 | Expedium Spine System | Medos International SARL | 2010 | 1 |
| 0 (this device) | K122226 | Revere Stabilization System | Globus Medical, Inc. | 2012 | — |
| +1 | K124058 | Creo Stabilization System | Globus Medical, Inc. | 2013 | — |
| +2 | K143633 | CREO Stabilization System | Globus Medical, Inc. | 2015 | — |
| +1 | K123783 | Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol Implants | Globus Medical, Inc. | 2013 | — |
| +2 | K150552 | ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS | Globus Medical, Inc. | 2015 | 1 |
| +1 | K133350 | Revere Stabilization System | Globus Medical, Inc. | 2014 | — |
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 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 8 | 0 |
| 2000 | 11 | 0 |
| 2001 | 17 | 0 |
| 2002 | 6 | 0 |
| 2003 | 10 | 0 |
| 2004 | 21 | 0 |
| 2005 | 21 | 0 |
| 2006 | 9 | 0 |
| 2007 | 7 | 0 |
| 2008 | 9 | 0 |
| 2009 | 11 | 0 |
| 2010 | 4 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 7 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 13 | 0 |
| 2019 | 11 | 0 |
| 2020 | 15 | 0 |
| 2021 | 13 | 1 |
| 2022 | 21 | 0 |
| 2023 | 31 | 0 |
| 2024 | 40 | 0 |
| 2025 | 33 | 0 |
| 2026 | 30 | 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? (9)
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…System Product Codes MNH, MNI, KWQ, KWP, NKB Regulatory Class Ill, Panel Code 87 Predicate(s): REVERE® Stabilization System (K061 202, K081 195, K091 782, K1 00788 & K1 11479) REVERE® 4.5 Stabiliza… | 2006 |
| * | K081195 | Revere Uniplanar ScrewsSummary page 1…Product Codes MNH, MNI, KWQ, KWP, NKB Regulatory Class Ill, Panel Code 87 Predicate(s): REVERE® Stabilization System (K061 202, K081 195, K091 782, K1 00788 & K1 11479) REVERE® 4.5 Stabilization Syste… | 2008 |
| * | K091782 | Revere 6.35 Stabilization SystemSummary page 1…Product Codes MNH, MNI, KWQ, KWP, NKB Regulatory Class Ill, Panel Code 87 Predicate(s): REVERE® Stabilization System (K061 202, K081 195, K091 782, K1 00788 & K1 11479) REVERE® 4.5 Stabilization System (K1 1339… | 2009 |
| * | K100788 | Cocr RodsSummary page 1…Regulatory Class Ill, Panel Code 87 Predicate(s): REVERE® Stabilization System (K061 202, K081 195, K091 782, K1 00788 & K1 11479) REVERE® 4.5 Stabilization System (K1 13395) REVOLVE® Stabilization System (K1 114… | 2010 |
| * | K111479 | Revere CrosstopSummary page 1…latory Class Ill, Panel Code 87 Predicate(s): REVERE® Stabilization System (K061 202, K081 195, K091 782, K1 00788 & K1 11479) REVERE® 4.5 Stabilization System (K1 13395) REVOLVE® Stabilization System (K1 11449)… | 2011 |
| * | K113395 | Revere 4.5 Stabilization SystemSummary page 1…bilization System (K061 202, K081 195, K091 782, K1 00788 & K1 11479) REVERE® 4.5 Stabilization System (K1 13395) REVOLVE® Stabilization System (K1 11449) Synthes® USS (K082572) DePuy Expe… | 2012 |
| * | K111449 | Revolve Additional ImplantsSummary page 1…K1 00788 & K1 11479) REVERE® 4.5 Stabilization System (K1 13395) REVOLVE® Stabilization System (K1 11449) Synthes® USS (K082572) DePuy Expedium® (K1 01070) Purpose: The purpose of this submission i… | 2011 |
| * | K082572 | Uss Iliosacral, Uss PolyaxialSummary page 1…0788 & K1 11479) REVERE® 4.5 Stabilization System (K1 13395) REVOLVE® Stabilization System (K1 11449) Synthes® USS (K082572) DePuy Expedium® (K1 01070) Purpose: The purpose of this submission is to request clearance for specialty rods… | 2008 |
| * | K101070 | Expedium Spine SystemSummary page 1….5 Stabilization System (K1 13395) REVOLVE® Stabilization System (K1 11449) Synthes® USS (K082572) DePuy Expedium® (K1 01070) Purpose: The purpose of this submission is to request clearance for specialty rods, HA coated screws, closed head screws, and w… | 2010 |
What descends from it? (225)
See all 2258 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K124058 | Creo Stabilization System | 2013 | 172 |
| K123783 | Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol Implants | 2013 | 97 |
| K133350 | Revere Stabilization System | 2014 | 93 |
| K180210 | CREO® Stabilization System | 2018 | 88 |
| K141804 | Polaris Spinal System - HA Coated | 2014 | 21 |
| K173508 | Everest Spinal System | 2018 | 9 |
| K132403 | Annextm Adjacent Level System | 2014 | 2 |
| K231443 | Mini-OSTEO Pedicle Fixation System | 2023 | 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 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 14 of the 176 ancestors have a recall of any class.
- Of its descendants, K124058 (Globus Medical, Inc., 2013) has gone furthest, with 172 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. 2012, 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…
Read the full statement (290 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 lordlosis, Scheuermann's disease), fracture, pseudoarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are Ti-sacrum/ilium.
When used as an anterolateral thoracolumbar system, the REVERE® 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-L5.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122226 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122226: Revere Stabilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122226
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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