510(k) · Cleared
ClearedDVX Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bk Meditech, Co., Ltd. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jun 4, 2008 as substantially equivalent to K053623 (N-Spine, Inc., 2006) and 1 other predicate after a 65-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it.
- Decided
- Jun 4, 2008
- Review
- 65 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K000319 (2000). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 3 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- 2 generations backK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- 1 generation backK072436 Mega Spine SystemBk Meditech, Co., Ltd. · 2007
- This deviceK080876 DVX Spine SystemBk Meditech, Co., Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK090424 DVX Spine SystemBk Meditech, Co., Ltd. · 2009
Most influential descendants
Showing 1 of 1 · See all- K090424DVX Spine SystemBk Meditech, Co., Ltd. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −3 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| −2 | K031585 | U&I, Optima, Spinal System | U&I Corp., America | 2003 | 5 |
| −1 | K072436 | Mega Spine System | Bk Meditech, Co., Ltd. | 2007 | — |
| 0 (this device) | K080876 | DVX Spine System | Bk Meditech, Co., Ltd. | 2008 | — |
| +1 | K090424 | DVX Spine System | Bk Meditech, Co., Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 4 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 MNH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K053623 | Nfix Fusion SystemSummary page 1…Orthopedic; MNH SUBSTANTIALLY EQUIVALENT TO: The DVX Spine System, is substantially equivalent to the NFix Fusion System cleared for market by N Spine, Inc. under K053623, and to MEGA Spine System (K072436) for the cross-link member. The DVX Spine System is equivalent to the N Spine system and the M… | 2006 |
| * | K072436 | Mega Spine SystemSummary page 1…Y EQUIVALENT TO: The DVX Spine System, is substantially equivalent to the NFix Fusion System cleared for market by N Spine, Inc. under K053623, and to MEGA Spine System (K072436) for the cross-link member. The DVX Spine System is equivalent to the N Spine system and the MEGA Spine cross-link member with re… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090424 | DVX Spine System | 2009 | 0 |
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 2.3 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K090424 (Bk Meditech, Co., Ltd., 2009) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K053623.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The DVX Spine System is intended for posterior, noncervical, pedicle fixation in order 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, including degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis…
Read the full statement (131 words)
The DVX Spine System is intended for posterior, noncervical, pedicle fixation in order 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, including degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the DVX Spine System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 and below), with removal of the implants after the attainment of solid fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080876 · printed Nov 4, 2026
Cite this page
510(k) Report. “K080876: DVX Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080876
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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