510(k) · Cleared
ClearedVertex Reconstruction System, Vertex Select Reconstruction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Soafamor Danek · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Aug 6, 2009 as substantially equivalent to K080805 (Medtronic Sofamor Danek, 2008) and 2 other predicates after a 90-day review. Its family tree reaches back 5 generations to 1985. 138 later devices descend from it.
- Decided
- Aug 6, 2009
- Review
- 90 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K853033 (1985). 19 ancestors in all. 138 later devices descend from it, 6 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 deviceK091365 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Soafamor Danek · 2009
- Descendant · cites it directly · 106 of its ownK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
- Descendant · cites it directly · 102 of its ownK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
- Descendant · 2 generations on · 75 of its ownK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
- Descendant · 3 generations on · 70 of its ownK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
- Descendant · 2 generations on · 67 of its ownK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
Showing 5 of 138 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 138 · See all- K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011 · cites it directly106descendants
- K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012 · cites it directly102descendants
- K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC) · 2013 · 2 generations on75descendants
- K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013 · 3 generations on70descendants
- K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · 2 generations on67descendants
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) | K091365 | Vertex Reconstruction System, Vertex Select Reconstruction System | Medtronic Soafamor Danek | 2009 | — |
| +1 | K110522 | Vertex Reconstruction System, Vertex Select Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| +1 | 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 |
| +3 | K131615 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2013 | — |
| +2 | K133746 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2014 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 9 | 0 |
| 2015 | 8 | 0 |
| 2016 | 5 | 0 |
| 2017 | 11 | 0 |
| 2018 | 8 | 0 |
| 2019 | 5 | 0 |
| 2020 | 15 | 0 |
| 2021 | 8 | 0 |
| 2022 | 9 | 0 |
| 2023 | 13 | 0 |
| 2024 | 13 | 0 |
| 2025 | 11 | 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 KWP? 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? (3)
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 |
|---|---|---|---|
| * | K080805 | Modification to Vertex Reconstruction SystemSummary page 2…tially equivalent to other commercially available posterior fixation systems and other pre-enactment devices including the VERTEX® Reconstruction System in K080805 (S.E. 4/18/08), K082728 (S.E. 1/16/09), and K052734 (S.E. 10/21/05). The results of mechanical testing performed for the… | 2008 |
| * | K082728 | Vertex Recontruction System, Vertex Select Reconstruction SystemSummary page 2…er commercially available posterior fixation systems and other pre-enactment devices including the VERTEX® Reconstruction System in K080805 (S.E. 4/18/08), K082728 (S.E. 1/16/09), and K052734 (S.E. 10/21/05). The results of mechanical testing performed for the subject VERTEX® Re… | 2009 |
| * | K052734 | Modification to: Vertex Reconstruction SystemSummary page 2…sterior fixation systems and other pre-enactment devices including the VERTEX® Reconstruction System in K080805 (S.E. 4/18/08), K082728 (S.E. 1/16/09), and K052734 (S.E. 10/21/05). The results of mechanical testing performed for the subject VERTEX® Reconstruction System components were… | 2005 |
What descends from it? (138)
See all 1386 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110522 | Vertex Reconstruction System, Vertex Select Reconstruction System | 2011 | 106 |
| K113593 | Nextgen Altius Oct System | 2012 | 102 |
| K123656 | Vertex Reconstruction System, Vertex Select Reconstruction System | 2013 | 39 |
| K163375 | INFINITY™ OCT System | 2017 | 16 |
| K121877 | Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod… | 2013 | 4 |
| K181350 | ASTRA-OCT Spine System | 2018 | 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 24 years and passes through 5 companies; a new generation was cleared every 3.8 years on median.
- 2 of the 19 ancestors have a recall of any class.
- Of its descendants, K110522 (Medtronic Sofamor Danek USA, Inc., 2011) has gone furthest, with 106 descendants of its own.
- 3 other devices also cite its predicate K080805.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
When intended as an adjunct to fusion of the occipitocervical spine, cervical spine,.and the thoracic spine, (Occiput-T3), the VERTEX® Reconstruction System is indicated for skeletally mature patients using allograft and/or autograft 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…
Read the full statement (264 words)
When intended as an adjunct to fusion of the occipitocervical spine, cervical spine,.and the thoracic spine, (Occiput-T3), the VERTEX® Reconstruction System is indicated for skeletally mature patients using allograft and/or autograft 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 Components:PlateRod/Plates/Rods/OccipitalScrews/Hooks
The occipitocervical plate rods, 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.
Occipitocervical constructs require bilateral fixation to C2 and below.
Note: Segmental fixation is recommended for these constructs.
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 (C1-T3) spine.
Multi-axialScrews/Connectors
The use of multi-axial screws are limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine. Titanium ATLAS® Cable System to be used with the VERTEX® Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.
In order to achieve additional levels of fixation, the VERTEX® Reconstruction System may be connected to the CD HORIZON® Spinal System rods with the VERTEX® rod connectors. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091365 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091365: Vertex Reconstruction System, Vertex Select Reconstruction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091365
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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