510(k) · Decided
DecidedRevere 4.5 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 Jun 14, 2012 as substantially equivalent to K061202 (Globus Medical, Inc., 2006) and 6 other predicates after a 210-day review. Its family tree reaches back 10 generations to 2004. 1 of the 369 devices in its family, counting itself, has a Class I recall. 260 later devices descend from it.
- Decided
- Jun 14, 2012
- Review
- 210 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 10 generations to K040583 (2004). 108 ancestors in all, the oldest K781443 (1978). 260 later devices descend from it, 10 citing it directly. 1 of the 369 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 6 generations between
- 3 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 2 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 1 generation backK102807 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2010
- This deviceK113395 Revere 4.5 Stabilization SystemGlobus Medical, Inc. · 2012
- Descendant · cites it directly · 225 of its ownK122226 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 · 2 generations on · 97 of its ownK123783 Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc. · 2013
- Descendant · 3 generations on · 96 of its ownK150552 ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc. · 2015 · Recalled
Show all 10 generations
- Root · 10 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 9 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 8 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 7 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 6 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 5 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 4 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 3 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 2 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 1 generation backK102807 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2010
- This deviceK113395 Revere 4.5 Stabilization SystemGlobus Medical, Inc. · 2012
Showing 5 of 260 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 260 · See all- K122226Revere Stabilization SystemGlobus Medical, Inc. · 2012 · cites it directly225descendants
- 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 · 2 generations on97descendants
- K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc. · 2015 · 3 generations on96descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −9 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −8 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −7 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −6 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −5 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −4 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −3 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −2 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −1 | K102807 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2010 | — |
| 0 (this device) | K113395 | Revere 4.5 Stabilization System | Globus Medical, Inc. | 2012 | — |
| +1 | 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 | — |
| +2 | K123783 | Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol Implants | Globus Medical, Inc. | 2013 | — |
| +3 | K150552 | ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS | Globus Medical, Inc. | 2015 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 9 | 0 |
| 2001 | 10 | 0 |
| 2002 | 3 | 0 |
| 2003 | 8 | 0 |
| 2004 | 16 | 0 |
| 2005 | 14 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 6 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 7 | 0 |
| 2015 | 11 | 0 |
| 2016 | 5 | 0 |
| 2017 | 14 | 0 |
| 2018 | 15 | 0 |
| 2019 | 13 | 0 |
| 2020 | 15 | 0 |
| 2021 | 15 | 1 |
| 2022 | 22 | 0 |
| 2023 | 32 | 0 |
| 2024 | 42 | 0 |
| 2025 | 33 | 0 |
| 2026 | 31 | 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…em, Adolescent ) Idiopathic Scoliosis Product Codes MNH, MNI, KWQ, KWP, NKB, OSH Regulatory Class Il and Ill, Panel Code 87. Predicate(s): REVERE?® Stabilization System K061202, K091782 & K100788 Medtronic CD Horizon® Spinal System K091445 &K102807 Synthes Small Stature USS K994121 & K103287 Purpose: Th… | 2006 |
| * | K091782 | Revere 6.35 Stabilization SystemSummary page 1…scent ) Idiopathic Scoliosis Product Codes MNH, MNI, KWQ, KWP, NKB, OSH Regulatory Class Il and Ill, Panel Code 87. Predicate(s): REVERE?® Stabilization System K061202, K091782 & K100788 Medtronic CD Horizon® Spinal System K091445 &K102807 Synthes Small Stature USS K994121 & K103287 Purpose: The purpose… | 2009 |
| * | K100788 | Cocr RodsSummary page 1…iopathic Scoliosis Product Codes MNH, MNI, KWQ, KWP, NKB, OSH Regulatory Class Il and Ill, Panel Code 87. Predicate(s): REVERE?® Stabilization System K061202, K091782 & K100788 Medtronic CD Horizon® Spinal System K091445 &K102807 Synthes Small Stature USS K994121 & K103287 Purpose: The purpose of this s… | 2010 |
| * | K091445 | CD Horizon Spinal SystemSummary page 1…WQ, KWP, NKB, OSH Regulatory Class Il and Ill, Panel Code 87. Predicate(s): REVERE?® Stabilization System K061202, K091782 & K100788 Medtronic CD Horizon® Spinal System K091445 &K102807 Synthes Small Stature USS K994121 & K103287 Purpose: The purpose of this submission is to request clearance of the REV… | 2010 |
| * | K102807 | CD Horizon Spinal SystemSummary page 1…NKB, OSH Regulatory Class Il and Ill, Panel Code 87. Predicate(s): REVERE?® Stabilization System K061202, K091782 & K100788 Medtronic CD Horizon® Spinal System K091445 &K102807 Synthes Small Stature USS K994121 & K103287 Purpose: The purpose of this submission is to request clearance of the REVERE® 4.5… | 2010 |
| * | K994121 | Small Stature UssSummary page 1…ll, Panel Code 87. Predicate(s): REVERE?® Stabilization System K061202, K091782 & K100788 Medtronic CD Horizon® Spinal System K091445 &K102807 Synthes Small Stature USS K994121 & K103287 Purpose: The purpose of this submission is to request clearance of the REVERE® 4.5 Stabilization System for skeletall… | 2000 |
| * | K103287 | Synthes 6.0 Cocr and CPT TI-3 RodsSummary page 1…Code 87. Predicate(s): REVERE?® Stabilization System K061202, K091782 & K100788 Medtronic CD Horizon® Spinal System K091445 &K102807 Synthes Small Stature USS K994121 & K103287 Purpose: The purpose of this submission is to request clearance of the REVERE® 4.5 Stabilization System for skeletally mature a… | 2011 |
What descends from it? (260)
See all 26010 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122226 | Revere Stabilization System | 2012 | 225 |
| K124058 | Creo Stabilization System | 2013 | 172 |
| K180210 | CREO® Stabilization System | 2018 | 88 |
| K131615 | Polaris Spinal System | 2013 | 70 |
| K121922 | Beacon Stabilization System | 2012 | 9 |
| K181139 | OLYMPIC Posterior Spinal Fixation System | 2018 | 8 |
| K241519 | Invictus® Small Stature Spinal Fixation System | 2024 | 2 |
| K181068 | CREO® Stabilization System, REVERE® Stabilization System | 2018 | 2 |
| K133366 | Orthros Posterior Stabilization System | 2014 | 2 |
| K253739 | SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5… | 2026 | 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 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 4 months on median.
- 12 of the 108 ancestors have a recall of any class.
- Of its descendants, K122226 (Globus Medical, Inc., 2012) has gone furthest, with 225 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® 4.5 Stabilization System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients (including small stature) and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined…
Read the full statement (206 words)
The REVERE® 4.5 Stabilization System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients (including small stature) and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann’s Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis).
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the REVERE® 4.5 Stabilization System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The REVERE® 4.5 Stabilization System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
In order to achieve additional levels of fixation in skeletally mature patients, the REVERE® 4.5 Stabilization System rods may be connected to the REVERE® Stabilization System (5.5mm or 6.35mm rod) or ELLIPSE® Occipito-Cervico-Thoracic Spinal System (3.5mm rod) using corresponding connectors. Refer to the REVERE® or ELLIPSE® system package insert for instructions and indications of use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K113395 · printed Nov 5, 2026
Cite this page
510(k) Report. “K113395: Revere 4.5 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/K113395
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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