510(k) · Cleared
ClearedMega Plus MIS 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 Aug 11, 2020 as substantially equivalent to K183080 (Bk Meditech, Co., Ltd., 2018) and 3 other predicates after a 119-day review. Its family tree reaches back 17 generations to 2001.
- Decided
- Aug 11, 2020
- Review
- 119 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 17 generations to K003155 (2001). 405 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet.
- Root · 17 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 13 generations between
- 3 generations backK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
- 2 generations backK173180 Mega Plus Spine SystemBk Meditech, Co., Ltd. · 2018
- 1 generation backK183080 Mega Plus Spine SystemBk Meditech, Co., Ltd. · 2018
- This deviceK200981 Mega Plus MIS Spine SystemBk Meditech, Co., Ltd. · 2020
Show all 17 generations
- Root · 17 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 16 generations backK012254 VBROsteotech, Inc. · 2001
- 15 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 14 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 13 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 12 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 11 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 10 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 9 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 8 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
- 7 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 6 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
- 5 generations backK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 4 generations backK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
- 3 generations backK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
- 2 generations backK173180 Mega Plus Spine SystemBk Meditech, Co., Ltd. · 2018
- 1 generation backK183080 Mega Plus Spine SystemBk Meditech, Co., Ltd. · 2018
- This deviceK200981 Mega Plus MIS Spine SystemBk Meditech, Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −16 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −15 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −14 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −13 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −12 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −11 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −10 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −9 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −8 | K061938 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2006 | — |
| −7 | K062427 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −6 | K070742 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | 2007 | — |
| −5 | K110522 | Vertex Reconstruction System, Vertex Select Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −4 | K113593 | Nextgen Altius Oct System | Biomet Spine (Aka Ebi, LLC) | 2012 | — |
| −3 | K123549 | Polaris Spinal System - Ballista II Percutaneous Screw Placement System | Biomet Spine (Aka Ebi, LLC) | 2013 | 2 |
| −2 | K173180 | Mega Plus Spine System | Bk Meditech, Co., Ltd. | 2018 | — |
| −1 | K183080 | Mega Plus Spine System | Bk Meditech, Co., Ltd. | 2018 | — |
| 0 (this device) | K200981 | Mega Plus MIS Spine System | Bk Meditech, 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 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 9 | 0 |
| 1996 | 9 | 0 |
| 1997 | 10 | 0 |
| 1998 | 17 | 0 |
| 1999 | 16 | 0 |
| 2000 | 25 | 0 |
| 2001 | 28 | 0 |
| 2002 | 24 | 0 |
| 2003 | 23 | 0 |
| 2004 | 39 | 0 |
| 2005 | 36 | 0 |
| 2006 | 26 | 0 |
| 2007 | 17 | 0 |
| 2008 | 26 | 0 |
| 2009 | 22 | 0 |
| 2010 | 19 | 0 |
| 2011 | 12 | 0 |
| 2012 | 8 | 0 |
| 2013 | 4 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 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 |
|---|---|---|---|
| * | K183080 | Mega Plus Spine SystemSummary page 4…use. The implants will be provided non-sterile. The locking bolts utilized as part of the proposed system are identical to those of the Mega Plus Spine System (K173180, K183080). The crosslinks and additional universal instrument components that may be utilized as part of the subject system were cleared p… | 2018 |
| * | K151648 | Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Summary page 5…Model Name Type K183080 Mega Plus Spine System BK Meditech Co., Ltd. Primary K151648 Valencia MIS Pedicle Screw Altus Partners, LLC Additional System K171421… | 2015 |
| * | K171421 | VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSummary page 5…tem BK Meditech Co., Ltd. Primary K151648 Valencia MIS Pedicle Screw Altus Partners, LLC Additional System K171421 VERTICALE® Posterior Silony medical GmbH Additional Spinal Fixat… | 2018 |
| * | K110280 | Revlok Fenestrated Screw SystemSummary page 5…System K171421 VERTICALE® Posterior Silony medical GmbH Additional Spinal Fixation System K110280 REVLOK™ Fenestrated Globus Medical Inc. Additional Screw System… | 2011 |
| † | K173180 | Mega Plus Spine System | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 19 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 35 of the 405 ancestors have a recall of any class.
- 1 other device also cites its predicate K183080.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 MIS 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).
The Mega Plus MIS Spine System can be used in an open approach and percutaneous approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200981 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200981: Mega Plus MIS 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/K200981
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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