510(k) · Cleared
ClearedVertex Reconstruction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Sep 23, 2005 as substantially equivalent to K982322 (Synthes (Usa), 1998) and 4 other predicates after a 22-day review. Its family tree reaches back 3 generations to 1985. 180 later devices descend from it.
- Decided
- Sep 23, 2005
- Review
- 22 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K853033 (1985). 8 ancestors in all. 180 later devices descend from it, 7 citing it directly.
- Root · 3 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 2 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 1 generation backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- This deviceK052402 Vertex Reconstruction SystemMedtronic Sofamor Danek · 2005
- Descendant · cites it directly · 175 of its ownK052734 Modification to: Vertex Reconstruction SystemMedtronic Sofamor Danek · 2005
- Descendant · cites it directly · 151 of its ownK062879 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 · 138 of its ownK091365 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Soafamor Danek · 2009
- Descendant · 2 generations on · 106 of its ownK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
Showing 5 of 180 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 180 · See all- K052734Modification to: Vertex Reconstruction SystemMedtronic Sofamor Danek · 2005 · cites it directly175descendants
- K062879Traverse Oct Spinal Fixation SystemMedtronic Sofamor Danek, Inc. · 2006 · cites it directly151descendants
- K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007 · cites it directly150descendants
- K091365Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Soafamor Danek · 2009 · 2 generations on138descendants
- K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011 · 2 generations on106descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −2 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −1 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| 0 (this device) | K052402 | Vertex Reconstruction System | Medtronic Sofamor Danek | 2005 | — |
| +1 | K052734 | Modification to: Vertex Reconstruction System | Medtronic Sofamor Danek | 2005 | — |
| +1 | K062879 | Traverse Oct Spinal Fixation System | Medtronic Sofamor Danek, Inc. | 2006 | — |
| +1 | K070742 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | 2007 | — |
| +2 | K091365 | Vertex Reconstruction System, Vertex Select Reconstruction System | Medtronic Soafamor Danek | 2009 | — |
| +2 | K110522 | Vertex Reconstruction System, Vertex Select Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 7 | 0 |
| 2013 | 8 | 0 |
| 2014 | 12 | 0 |
| 2015 | 10 | 0 |
| 2016 | 9 | 0 |
| 2017 | 12 | 0 |
| 2018 | 9 | 0 |
| 2019 | 6 | 0 |
| 2020 | 17 | 0 |
| 2021 | 9 | 0 |
| 2022 | 9 | 0 |
| 2023 | 19 | 0 |
| 2024 | 14 | 0 |
| 2025 | 13 | 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? (5)
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 |
|---|---|---|---|
| * | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSummary page 2…substantially equivalent to similar legally marketed occipito-cervico-thoracic fixation devices including the Synthes Spine Occipital-Cervical Plate/Rod and Hook System (K982322), the OctaFix Occipital Cervical Plating System (K021009), the Synthes CerviFix® System (K023675), the Summit OCT Spinal System (… | 1998 |
| * | K021009 | Octafix Occipital Cervical Plating SystemSummary page 2…pito-cervico-thoracic fixation devices including the Synthes Spine Occipital-Cervical Plate/Rod and Hook System (K982322), the OctaFix Occipital Cervical Plating System (K021009), the Synthes CerviFix® System (K023675), the Summit OCT Spinal System (K010681), and the Interpore Cross International OCT Rod a… | 2002 |
| * | K023675 | Synthes Cervifix/ AxonSummary page 2…ncluding the Synthes Spine Occipital-Cervical Plate/Rod and Hook System (K982322), the OctaFix Occipital Cervical Plating System (K021009), the Synthes CerviFix® System (K023675), the Summit OCT Spinal System (K010681), and the Interpore Cross International OCT Rod and Plate System (K022048). === Page 3 =… | 2002 |
| * | K010681 | Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemSummary page 2…vical Plate/Rod and Hook System (K982322), the OctaFix Occipital Cervical Plating System (K021009), the Synthes CerviFix® System (K023675), the Summit OCT Spinal System (K010681), and the Interpore Cross International OCT Rod and Plate System (K022048). A SERYIC P ., J / DEPARTMENT OF HEAL… | 2001 |
| * | K022048 | Interpore Cross International (Ici) Occipito-Cervico-Thoracic (Oct) Rod and Plate SystemSummary page 2…Plating System (K021009), the Synthes CerviFix® System (K023675), the Summit OCT Spinal System (K010681), and the Interpore Cross International OCT Rod and Plate System (K022048). A SERYIC P ., J / DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service & LALYY ot 1, v, b, “¥vg1a F… | 2002 |
What descends from it? (180)
See all 1807 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052734 | Modification to: Vertex Reconstruction System | 2005 | 175 |
| K062879 | Traverse Oct Spinal Fixation System | 2006 | 151 |
| K070742 | Modification to Vertex Reconstruction System | 2007 | 150 |
| K071942 | Modification to Vertex Reconstruction System | 2007 | 24 |
| K133288 | Caspian Oct Spinal System | 2014 | 18 |
| K171444 | YUKON OCT Spinal System | 2017 | 13 |
| K180851 | VERTEX™ Reconstruction System | 2018 | 8 |
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 20 years and passes through 4 companies; a new generation was cleared every 6.8 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K052734 (Medtronic Sofamor Danek, 2005) has gone furthest, with 175 descendants of its own.
- 3 other devices also cite its predicate K982322.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 to promote fusion of the occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-T3), the VERTEX® Reconstruction 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 (220 words)
When intended to promote fusion of the occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-T3), the VERTEX® Reconstruction 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 plate/rods, occipital screws (3.5mm, 4.0mm and 4.5mm cancellous), 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 plate/rod requires 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-axial Screws/Connectors
The use of multi-axial screws (3.5mm and 4.0mm cancellous, and 4.0mm cortical) are limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine.
Titanium ATLAS™ Cable System used with the VERTEX® Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K052402 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052402: Vertex 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/K052402
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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