510(k) · Cleared
ClearedModification to: Vertex 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 Oct 21, 2005 as substantially equivalent to K052402 (Medtronic Sofamor Danek, 2005) and 2 other predicates after a 21-day review. Its family tree reaches back 4 generations to 1985. 175 later devices descend from it.
- Decided
- Oct 21, 2005
- Review
- 21 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K853033 (1985). 13 ancestors in all. 175 later devices descend from it, 7 citing it directly.
- Root · 4 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 3 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 2 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 1 generation backK052402 Vertex Reconstruction SystemMedtronic Sofamor Danek · 2005
- This deviceK052734 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 · cites it directly · 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
- Descendant · 2 generations on · 102 of its ownK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
Showing 5 of 175 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 175 · See all- 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 · cites it directly138descendants
- K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011 · 2 generations on106descendants
- K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012 · 2 generations on102descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −3 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −2 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −1 | K052402 | Vertex Reconstruction System | Medtronic Sofamor Danek | 2005 | — |
| 0 (this device) | 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 | — |
| +1 | 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 | — |
| +2 | K113593 | Nextgen Altius Oct System | Biomet Spine (Aka Ebi, LLC) | 2012 | — |
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 |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 7 | 0 |
| 2013 | 8 | 0 |
| 2014 | 11 | 0 |
| 2015 | 10 | 0 |
| 2016 | 8 | 0 |
| 2017 | 12 | 0 |
| 2018 | 9 | 0 |
| 2019 | 6 | 0 |
| 2020 | 17 | 0 |
| 2021 | 9 | 0 |
| 2022 | 9 | 0 |
| 2023 | 19 | 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 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 |
|---|---|---|---|
| * | K052402 | Vertex Reconstruction SystemSummary page 2…trating that the subject VERTEX® Reconstruction System components are substantially equivalent to VERTEX® pre-curved occipital plate/rod components previously cleared in K052402, and to the set screws cleared in K052180 and K042498. DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2005 |
| * | K052180 | Modification to Vertex Reconstruction SystemSummary page 2…ction System components are substantially equivalent to VERTEX® pre-curved occipital plate/rod components previously cleared in K052402, and to the set screws cleared in K052180 and K042498. DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Servi… | 2005 |
| * | K042498 | Vertex Reconstruction SystemSummary page 2…components are substantially equivalent to VERTEX® pre-curved occipital plate/rod components previously cleared in K052402, and to the set screws cleared in K052180 and K042498. DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service… | 2004 |
What descends from it? (175)
See all 1757 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062879 | Traverse Oct Spinal Fixation System | 2006 | 151 |
| K070742 | Modification to Vertex Reconstruction System | 2007 | 150 |
| K091365 | Vertex Reconstruction System, Vertex Select Reconstruction System | 2009 | 138 |
| K071942 | Modification to Vertex Reconstruction System | 2007 | 24 |
| K062934 | Sierra | 2006 | 21 |
| K163375 | INFINITY™ OCT System | 2017 | 16 |
| K121979 | Pass Oct Spinal System | 2013 | 14 |
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.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K062879 (Medtronic Sofamor Danek, Inc., 2006) has gone furthest, with 151 descendants of its own.
- 6 other devices also cite its predicate K052402.
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. OccipitocervicalPlate/Rod/OccipitalScrews/Hooks The…
Read the full statement (225 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.
OccipitocervicalPlate/Rod/OccipitalScrews/Hooks
The occipitocervical plate/rods, occipital screws (3.5nm, 4.0mm and 4.5mm cancellous along with 4.0mm and 4.5mm cortical), and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and tihe 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.
HFooks 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 (Cl-T3) spine.
Multi-axial Screws/Connectors
The use of multi-axial screws (3.5ram and 4.0amm 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 ATLAST M Cable System used with the VERTEX® Reconstruction 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/K052734 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052734: Modification to: Vertex Reconstruction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052734
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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