510(k) · Cleared
ClearedModification to Endius Minit Posterior Cervical and Upper Thoracic Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endius, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Mar 10, 2008 as substantially equivalent to K070282 (Endius, Inc., 2007) after a 39-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Mar 10, 2008
- Review
- 39 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K003780 (2001). 8 ancestors in all, the oldest K991089 (1999). No later device cites it as a predicate yet.
- Root · 5 generations backK003780 Vertex Reconstruction SystemMedtronic Sofamor Danek, Inc. · 2001
- 4 generations backK042498 Vertex Reconstruction SystemMedtronic Sofamor Danek · 2004 · Recalled
- 3 generations backK052180 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2005
- 2 generations backK060683 Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc. · 2006
- 1 generation backK070282 Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc. · 2007
- This deviceK080258 Modification to Endius Minit Posterior Cervical and Upper Thoracic…Endius, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003780 | Vertex Reconstruction System | Medtronic Sofamor Danek, Inc. | 2001 | — |
| −4 | K042498 | Vertex Reconstruction System | Medtronic Sofamor Danek | 2004 | 1 |
| −3 | K052180 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | 2005 | — |
| −2 | K060683 | Endius Minit Posterior Cervical and Upper Thoracic Fixation System | Endius, Inc. | 2006 | — |
| −1 | K070282 | Endius Minit Posterior Cervical and Upper Thoracic Fixation System | Endius, Inc. | 2007 | — |
| 0 (this device) | K080258 | Modification to Endius Minit Posterior Cervical and Upper Thoracic Fixation… | Endius, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 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? (1)
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 |
|---|---|---|---|
| * | K070282 | Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemSummary page 2…ndius Minit PCT System January 30, 2008 5.5 Predicate Devices Device Namne(s) & 5 10(k) Number: * Endius Minit Posterior Cervical and Upper Thoracic Fixation System, K070282. 5.6 Device Description The proposed Endius Minit Posterior Cervical and Upper Thoracic Fixation System is a posterior system,… | 2007 |
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 7 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- 1 of the 8 ancestors has a recall of any class.
- 3 other devices also cite its predicate K070282.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
When intended to promote fusion of the cervical spine and the thoracic spine, (Cl-T3), the Endius Minit Posterior Cervical and Upper Thoracic Fixation System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. Hooks and Rods The hooks and rods are also intended to…
Read the full statement (158 words)
When intended to promote fusion of the cervical spine and the thoracic spine, (Cl-T3), the Endius Minit Posterior Cervical and Upper Thoracic Fixation System is indicated for the following:
DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C l-T3) spine.
Screws/Connectors
The use of screws is limited to placement in the Ti-T3 in treating thoracic conditions only.
Screws are not intended to be placed in the cervical spine.
Axial and Offset Rod Connectors
The Minit Posterior Cervical and Upper Thoracic Fixation System can also be linked to the TiTLE and TiTLE2 Polyaxial Spinal Systems offered by Endius Inc. using the Axial Rod Connectors, Dual Rod Connectors and the Tri Screw Dual Rod Connectors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080258 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080258: Modification to Endius Minit Posterior Cervical and Upper Thoracic Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080258
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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