510(k) · Cleared
ClearedMega Plus Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bk Meditech, Co., Ltd. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Dec 10, 2018 as substantially equivalent to K173180 (Bk Meditech, Co., Ltd., 2018) and 3 other predicates after a 35-day review. Its family tree reaches back 16 generations to 2001. 2 later devices descend from it.
- Decided
- Dec 10, 2018
- Review
- 35 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 16 generations to K003155 (2001). 322 ancestors in all, the oldest K781443 (1978). 2 later devices descend from it, 2 citing it directly.
- Root · 16 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 12 generations between
- 3 generations backK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
- 2 generations backK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
- 1 generation backK173180 Mega Plus Spine SystemBk Meditech, Co., Ltd. · 2018
- This deviceK183080 Mega Plus Spine SystemBk Meditech, Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK200981 Mega Plus MIS Spine SystemBk Meditech, Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK191655 MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd. · 2020
Show all 16 generations
- Root · 16 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 15 generations backK012254 VBROsteotech, Inc. · 2001
- 14 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 13 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 12 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 11 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 10 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 9 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 8 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 7 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
- 6 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 5 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
- 4 generations backK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 3 generations backK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
- 2 generations backK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
- 1 generation backK173180 Mega Plus Spine SystemBk Meditech, Co., Ltd. · 2018
- This deviceK183080 Mega Plus Spine SystemBk Meditech, Co., Ltd. · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −15 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −14 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −13 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −12 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −11 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −10 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −9 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −8 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −7 | K061938 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2006 | — |
| −6 | K062427 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −5 | K070742 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | 2007 | — |
| −4 | K110522 | Vertex Reconstruction System, Vertex Select Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −3 | K113593 | Nextgen Altius Oct System | Biomet Spine (Aka Ebi, LLC) | 2012 | — |
| −2 | K123549 | Polaris Spinal System - Ballista II Percutaneous Screw Placement System | Biomet Spine (Aka Ebi, LLC) | 2013 | 2 |
| −1 | K173180 | Mega Plus Spine System | Bk Meditech, Co., Ltd. | 2018 | — |
| 0 (this device) | K183080 | Mega Plus Spine System | Bk Meditech, Co., Ltd. | 2018 | — |
| +1 | K200981 | Mega Plus MIS Spine System | Bk Meditech, Co., Ltd. | 2020 | — |
| +1 | K191655 | MEGAFIX® Pedicle Screw Spinal System | Seohancare Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 6 | 0 |
| 1996 | 8 | 0 |
| 1997 | 7 | 0 |
| 1998 | 14 | 0 |
| 1999 | 10 | 0 |
| 2000 | 22 | 0 |
| 2001 | 22 | 0 |
| 2002 | 20 | 0 |
| 2003 | 20 | 0 |
| 2004 | 35 | 0 |
| 2005 | 31 | 0 |
| 2006 | 22 | 0 |
| 2007 | 10 | 0 |
| 2008 | 22 | 0 |
| 2009 | 17 | 0 |
| 2010 | 13 | 0 |
| 2011 | 7 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K173180 | Mega Plus Spine SystemSummary page 4…ecialized instruments are also available for the application and removal of the Mega Plus Spine System. Modifications to the Mega Plus Spine System from the clearance in K173180 include the addition of CoCr rods, the addition of LED and deformity type rods, and the inclusion of non-anodized screws for all… | 2018 |
| * | K111940 | S 100 Pedicle Screw SystemSummary page 5…Type K173180 Mega Plus Spine System BK MEDITECH CO., Primary Inc. K111940 S 100 Pedicle Screw System Renovis Additional K130176 Orthofix… | 2012 |
| * | K130176 | Firebird Spinal Fixation SystemSummary page 5…mary Inc. K111940 S 100 Pedicle Screw System Renovis Additional K130176 Orthofix Firebird Spinal Additional… | 2013 |
| * | K113666 | Xia 3 Spinal SystemSummary page 5…76 Orthofix Firebird Spinal Additional Fixation System K113666 XIA 3 Spinal System Stryker Spine Additional PERFORMANCE TESTING SUMMARY In support… | 2012 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 17 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 31 of the 322 ancestors have a recall of any class.
- Of its descendants, K200981 (Bk Meditech, Co., Ltd., 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Mega Plus Spine 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; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183080 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183080: Mega Plus Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183080
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