510(k) · Cleared
ClearedOctafix Occipital Cervical Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Concepts, Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Jun 18, 2002 as substantially equivalent to K011969 (Synthes (Usa), 2001) after an 82-day review. Its family tree reaches back 1 generation to 2001. 184 later devices descend from it.
- Decided
- Jun 18, 2002
- Review
- 82 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011969 (2001). 184 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK011969 Synthes Cervifix SystemSynthes (Usa) · 2001
- This deviceK021009 Octafix Occipital Cervical Plating SystemSpinal Concepts, Inc. · 2002
- Descendant · cites it directly · 180 of its ownK052402 Vertex Reconstruction SystemMedtronic Sofamor Danek · 2005
- Descendant · 2 generations on · 175 of its ownK052734 Modification to: Vertex Reconstruction SystemMedtronic Sofamor Danek · 2005
- Descendant · 2 generations on · 151 of its ownK062879 Traverse Oct Spinal Fixation SystemMedtronic Sofamor Danek, Inc. · 2006
- Descendant · 2 generations on · 150 of its ownK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
- Descendant · 3 generations on · 138 of its ownK091365 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Soafamor Danek · 2009
Showing 5 of 184 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 184 · See all- K052402Vertex Reconstruction SystemMedtronic Sofamor Danek · 2005 · cites it directly180descendants
- K052734Modification to: Vertex Reconstruction SystemMedtronic Sofamor Danek · 2005 · 2 generations on175descendants
- K062879Traverse Oct Spinal Fixation SystemMedtronic Sofamor Danek, Inc. · 2006 · 2 generations on151descendants
- K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007 · 2 generations on150descendants
- K091365Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Soafamor Danek · 2009 · 3 generations on138descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011969 | Synthes Cervifix System | Synthes (Usa) | 2001 | — |
| 0 (this device) | K021009 | Octafix Occipital Cervical Plating System | Spinal Concepts, Inc. | 2002 | — |
| +1 | K052402 | Vertex Reconstruction System | Medtronic Sofamor Danek | 2005 | — |
| +2 | K052734 | Modification to: Vertex Reconstruction System | Medtronic Sofamor Danek | 2005 | — |
| +2 | K062879 | Traverse Oct Spinal Fixation System | Medtronic Sofamor Danek, Inc. | 2006 | — |
| +2 | K070742 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | 2007 | — |
| +3 | K091365 | Vertex Reconstruction System, Vertex Select Reconstruction System | Medtronic Soafamor Danek | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 7 | 0 |
| 2013 | 8 | 0 |
| 2014 | 12 | 0 |
| 2015 | 11 | 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? (1)
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 |
|---|---|---|---|
| * | K011969 | Synthes Cervifix System | 2001 |
What descends from it? (184)
See all 1843 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?
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?
The OctaFix Occipital Cervical Plating System is intended to provide stabilization to promote fusion of the cervical spine and occipito-cervim-thoracic junction (occiput-T3) for the following indications: degenerative disc disease (neck pain of discogenic origin with degeneration of the disk as confirmed by patient history and radiological studies), [email protected], spinal stenosis, hcture/dislocation, adanto-axial fracture with instabhy…
Read the full statement (153 words)
The OctaFix Occipital Cervical Plating System is intended to provide stabilization to promote fusion of the cervical spine and occipito-cervim-thoracic junction (occiput-T3) for the following indications: degenerative disc disease (neck pain of discogenic origin with degeneration of the disk as confirmed by patient history and radiological studies), [email protected], spinal stenosis, hcture/dislocation, adanto-axial fracture with instabhy, occipito-cervical dislocation, revision of previous cervical spine fusion surgery and tumors.
The UBP I1 Cancellous and Cortical Bone Screws (3.5mm and 4mm diameters; 8mm-20mm threaded lengths) are used with the Oafiix Occipital Cervical Plating System to allow for occipital fixation. These UBP 11Bone Screws are limited to occipital fixation only.
The C-Fixm Cable System is used with the OctaFix Occipital Cervical Plating System to allow for wire/cable attachment to the posterior cervical spine.
The OctaFix 4mm Cannulated Side Loading Closed Screws are limited to placement in the upper thoracic spine vl-T3) for additional stab the indications specified above.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021009 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021009: Octafix Occipital Cervical Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021009
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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