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 Dec 11, 2007 as substantially equivalent to K052402 (Medtronic Sofamor Danek, 2005) and 1 other predicate after a 151-day review. Its family tree reaches back 5 generations to 1985. 24 later devices descend from it.
- Decided
- Dec 11, 2007
- Review
- 151 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K853033 (1985). 14 ancestors in all. 24 later devices descend from it, 2 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 deviceK071942 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
- Descendant · cites it directly · 16 of its ownK163375 INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 8 of its ownK180851 VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2018
- Descendant · cites it directly · 7 of its ownK093434 Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek · 2009
- Descendant · 2 generations on · 5 of its ownK111076 Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc. · 2011
- Descendant · 2 generations on · 3 of its ownK210449 Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic · 2021
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc. · 2017 · cites it directly16descendants
- K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2018 · 2 generations on8descendants
- K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek · 2009 · cites it directly7descendants
- K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc. · 2011 · 2 generations on5descendants
- K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic · 2021 · 2 generations on3descendants
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) | K071942 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | 2007 | — |
| +1 | K163375 | INFINITY™ OCT System | Medtronic Sofamor Danek USA, Inc. | 2017 | 5 |
| +2 | K180851 | VERTEX™ Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2018 | — |
| +1 | K093434 | Vertex Reconstruction System and Vertex Select Reconstruction System | Medtronic Sofamor Danek | 2009 | — |
| +2 | K111076 | Solanas Avalon Posterior Fixation System | Alphatec Spine, Inc. | 2011 | — |
| +2 | K210449 | Infinity™ OCT System, PASS OCT® Spinal System | Medtronic | 2021 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 5 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 5 | 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? (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 2…stantially equivalent to other commercially available posterior fixation systems and other pre-enactment devices including the VERTEX® Reconstruction System (K052402, SE 09/23/2005; K052734, SE 10/21/2005). The results of mechanical. testing performed for the subject VERTEX® Reconst… | 2005 |
| * | K052734 | Modification to: Vertex Reconstruction SystemSummary page 2…other commercially available posterior fixation systems and other pre-enactment devices including the VERTEX® Reconstruction System (K052402, SE 09/23/2005; K052734, SE 10/21/2005). The results of mechanical. testing performed for the subject VERTEX® Reconstruction System component… | 2005 |
What descends from it? (24)
See all 242 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 22 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K163375 (Medtronic Sofamor Danek USA, Inc., 2017) has gone furthest, with 16 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. 2007, 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 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 Components: Plate Rod/Plates/Rods/Occipital…
Read the full statement (259 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 Components: Plate Rod/Plates/Rods/Occipital Screws/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 (CI-T3) spine.
Multi-axial Screws/Connectors
The use of multi-axial screws are limited to placement in TI-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/K071942 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071942: 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/K071942
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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