510(k) · Cleared
ClearedBeacon 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 Jul 26, 2012 as substantially equivalent to K073172 (Globus Medical, Inc., 2007) and 6 other predicates after a 24-day review. Its family tree reaches back 11 generations to 2004. 9 later devices descend from it.
- Decided
- Jul 26, 2012
- Review
- 24 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 11 generations to K040583 (2004). 111 ancestors in all, the oldest K781443 (1978). 9 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 7 generations between
- 3 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 2 generations backK102807 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2010
- 1 generation backK113395 Revere 4.5 Stabilization SystemGlobus Medical, Inc. · 2012
- This deviceK121922 Beacon Stabilization SystemGlobus Medical, Inc. · 2012
- Descendant · cites it directly · 8 of its ownK152148 Fortress Pedicular Fixation SystemSpineology, Inc. · 2015
- Descendant · 2 generations on · 6 of its ownK160980 Threshold Pedicular Fixation System, Palisade Pedicular Fixation…Spineology, Inc. · 2016
- Descendant · 2 generations on · 3 of its ownK161694 Threshold™ Pedicular Fixation SystemSpineology, Inc. · 2016
- Descendant · 3 generations on · 2 of its ownK170266 Palisade™ Pedicular Fixation SystemSpineology, Inc. · 2017
- Descendant · 4 generations on · 1 of its ownK171438 Palisade™ Pedicular Fixation SystemSpineology, Inc. · 2017
Show all 11 generations
- Root · 11 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 10 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 9 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 8 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 7 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 6 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 5 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 4 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 3 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 2 generations backK102807 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2010
- 1 generation backK113395 Revere 4.5 Stabilization SystemGlobus Medical, Inc. · 2012
- This deviceK121922 Beacon Stabilization SystemGlobus Medical, Inc. · 2012
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K152148Fortress Pedicular Fixation SystemSpineology, Inc. · 2015 · cites it directly8descendants
- K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc. · 2016 · 2 generations on6descendants
- K161694Threshold™ Pedicular Fixation SystemSpineology, Inc. · 2016 · 2 generations on3descendants
- K170266Palisade™ Pedicular Fixation SystemSpineology, Inc. · 2017 · 3 generations on2descendants
- K171438Palisade™ Pedicular Fixation SystemSpineology, Inc. · 2017 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −10 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −9 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −8 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −7 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −6 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −5 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −4 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −3 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −2 | K102807 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2010 | — |
| −1 | K113395 | Revere 4.5 Stabilization System | Globus Medical, Inc. | 2012 | — |
| 0 (this device) | K121922 | Beacon Stabilization System | Globus Medical, Inc. | 2012 | — |
| +1 | K152148 | Fortress Pedicular Fixation System | Spineology, Inc. | 2015 | — |
| +2 | K160980 | Threshold Pedicular Fixation System, Palisade Pedicular Fixation System | Spineology, Inc. | 2016 | — |
| +2 | K161694 | Threshold™ Pedicular Fixation System | Spineology, Inc. | 2016 | — |
| +3 | K170266 | Palisade™ Pedicular Fixation System | Spineology, Inc. | 2017 | — |
| +4 | K171438 | Palisade™ Pedicular Fixation System | Spineology, Inc. | 2017 | — |
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 | 7 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 6 | 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? (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 |
|---|---|---|---|
| * | K073172 | Beacon Stabilization SystemSummary page 1…ystem Product Codes: MNH, MNI, KWQ, KWP, NKB Regulatory Class Ill, Panel Code: 87 Predicate(s): BEACON® Stabilization System (K0731 72, K09261 0 & K1 00788) REVERE® 4.5 Stabilization System (K1 13395) REVERE® Stabilization S… | 2007 |
| * | K092610 | Modification to Beacon Stabilization SystemSummary page 1…Product Codes: MNH, MNI, KWQ, KWP, NKB Regulatory Class Ill, Panel Code: 87 Predicate(s): BEACON® Stabilization System (K0731 72, K09261 0 & K1 00788) REVERE® 4.5 Stabilization System (K1 13395) REVERE® Stabilization System (K06… | 2009 |
| * | K100788 | Cocr RodsSummary page 1…Product Codes: MNH, MNI, KWQ, KWP, NKB Regulatory Class Ill, Panel Code: 87 Predicate(s): BEACON® Stabilization System (K0731 72, K09261 0 & K1 00788) REVERE® 4.5 Stabilization System (K1 13395) REVERE® Stabilization System (K061 202)… | 2010 |
| * | K113395 | Revere 4.5 Stabilization SystemSummary page 1…gulatory Class Ill, Panel Code: 87 Predicate(s): BEACON® Stabilization System (K0731 72, K09261 0 & K1 00788) REVERE® 4.5 Stabilization System (K1 13395) REVERE® Stabilization System (K061 202) REVOLVE® Stabilization System (K1 11449)… | 2012 |
| * | K061202 | Revere Stabilization SystemSummary page 1…N® Stabilization System (K0731 72, K09261 0 & K1 00788) REVERE® 4.5 Stabilization System (K1 13395) REVERE® Stabilization System (K061 202) REVOLVE® Stabilization System (K1 11449) Synthes® USS (K082572) Purpose: The purpose of… | 2006 |
| * | K111449 | Revolve Additional ImplantsSummary page 1…REVERE® 4.5 Stabilization System (K1 13395) REVERE® Stabilization System (K061 202) REVOLVE® Stabilization System (K1 11449) Synthes® USS (K082572) Purpose: The purpose of this submission is to request clearance for specialty rods a… | 2011 |
| * | K082572 | Uss Iliosacral, Uss PolyaxialSummary page 1…tem (K1 13395) REVERE® Stabilization System (K061 202) REVOLVE® Stabilization System (K1 11449) Synthes® USS (K082572) Purpose: The purpose of this submission is to request clearance for specialty rods and HA coated screws as additional implants… | 2008 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152148 | Fortress Pedicular Fixation System | 2015 | 8 |
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 8 years and passes through 4 companies; a new generation was cleared every 4 months on median.
- 12 of the 111 ancestors have a recall of any class.
- Of its descendants, K152148 (Spineology, Inc., 2015) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K073172.
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 BEACON® 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 (291 words)
The BEACON® 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, pseudloarthrbsis and failed previous fusion.
In addition, the BEACON® 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 (using REVERE® hooks), the BEACON® 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, pseudloarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are Ti -sacrum/ilium.
When used as an anterolateral thoracolumbar system, the BEACON® 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 lordlosis), fracture or dislocation of the thoracolumbar spine, pseudloarthrosis, 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/K121922 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121922: Beacon 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/K121922
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