510(k) · Cleared
ClearedTraverse Oct Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek, Inc. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Dec 22, 2006 as substantially equivalent to K052402 (Medtronic Sofamor Danek, 2005) and 1 other predicate after an 87-day review. Its family tree reaches back 5 generations to 1985. 151 later devices descend from it.
- Decided
- Dec 22, 2006
- Review
- 87 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K853033 (1985). 14 ancestors in all. 151 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 4 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 3 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 2 generations backK052402 Vertex Reconstruction SystemMedtronic Sofamor Danek · 2005
- 1 generation backK052734 Modification to: Vertex Reconstruction SystemMedtronic Sofamor Danek · 2005
- This deviceK062879 Traverse Oct Spinal Fixation SystemMedtronic Sofamor Danek, Inc. · 2006
- Descendant · cites it directly · 150 of its ownK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
- Descendant · 2 generations on · 106 of its ownK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
- Descendant · 3 generations on · 102 of its ownK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
- Descendant · 4 generations on · 75 of its ownK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
- Descendant · 5 generations on · 70 of its ownK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
Showing 5 of 151 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 151 · See all- K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007 · cites it directly150descendants
- K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011 · 2 generations on106descendants
- K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012 · 3 generations on102descendants
- K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC) · 2013 · 4 generations on75descendants
- K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013 · 5 generations on70descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −4 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −3 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −2 | K052402 | Vertex Reconstruction System | Medtronic Sofamor Danek | 2005 | — |
| −1 | K052734 | Modification to: Vertex Reconstruction System | Medtronic Sofamor Danek | 2005 | — |
| 0 (this device) | K062879 | Traverse Oct Spinal Fixation System | Medtronic Sofamor Danek, Inc. | 2006 | — |
| +1 | K070742 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | 2007 | — |
| +2 | 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 | — |
| +4 | K123549 | Polaris Spinal System - Ballista II Percutaneous Screw Placement System | Biomet Spine (Aka Ebi, LLC) | 2013 | 2 |
| +5 | K131615 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2013 | 5 | 0 |
| 2014 | 9 | 0 |
| 2015 | 8 | 0 |
| 2016 | 6 | 0 |
| 2017 | 12 | 0 |
| 2018 | 8 | 0 |
| 2019 | 6 | 0 |
| 2020 | 16 | 0 |
| 2021 | 8 | 0 |
| 2022 | 9 | 0 |
| 2023 | 16 | 0 |
| 2024 | 13 | 0 |
| 2025 | 12 | 0 |
| 2026 | 13 | 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 MNI? 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 |
|---|---|---|---|
| * | K052402 | Vertex Reconstruction SystemSummary page 1…isc Disease; Class: II; Product Code(s): KWP,MNI; and Regulation No.: 888.3050 and 888.3070 IV. Legally Marketed Devices: VERTEX® Reconstruction System (K052402/K052734) V. Description: The TRAVERSETM OCT Spinal Fixation System is intended to help provide immobilization a… | 2005 |
| * | K052734 | Modification to: Vertex Reconstruction SystemSummary page 1…ase; Class: II; Product Code(s): KWP,MNI; and Regulation No.: 888.3050 and 888.3070 IV. Legally Marketed Devices: VERTEX® Reconstruction System (K052402/K052734) V. Description: The TRAVERSETM OCT Spinal Fixation System is intended to help provide immobilization and stabi… | 2005 |
What descends from it? (151)
See all 1511 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070742 | Modification to Vertex Reconstruction System | 2007 | 150 |
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 21 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K070742 (Medtronic Sofamor Danek, 2007) has gone furthest, with 150 descendants of its own.
- 6 other devices also cite its predicate K052402.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
When intended to promote fusion of the occipitocervical spine, the cervical spine, and the thoracic spine, (Occiput-T3), the TRAVERSE OCT Spinal 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. Occipitocervical Plate/Rod/Occipital Screws/Hooks The…
Read the full statement (211 words)
When intended to promote fusion of the occipitocervical spine, the cervical spine, and the thoracic spine, (Occiput-T3), the TRAVERSE OCT Spinal 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.
Occipitocervical Plate/Rod/Occipital Screws/Hooks
The occipitocervical plates, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, these screws are limited to occipital fixation only. The screws are not intended to be placed in the cervical spine.
The use of the occipitocervical plates and rods requires bilateral fixation to C2 and below.
Note: segmental fixation is recommended for these constructs.
Hooks
The hooks are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Multi-Axial Screws/Connectors
The use of multi-axial screws is limited to placement of T1-T3. The screws are not intended to be placed in the cervical spine.
Titanium ATLAS® Cable used with the TRAVERSE OCT Spinal Fixation System allows for cable attachment to the posterior cervical or thoracic spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062879 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062879: Traverse Oct Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062879
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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