510(k) · Cleared
ClearedSynthes Cervifix System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Jul 19, 2001 after a 24-day review. The FDA summary names no predicate by number. 186 later devices descend from it.
- Decided
- Jul 19, 2001
- Review
- 24 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 0
186 later devices descend from it, 3 citing it directly.
- This deviceK011969 Synthes Cervifix SystemSynthes (Usa) · 2001
- Descendant · cites it directly · 184 of its ownK021009 Octafix Occipital Cervical Plating SystemSpinal Concepts, Inc. · 2002
- Descendant · 2 generations on · 180 of its ownK052402 Vertex Reconstruction SystemMedtronic Sofamor Danek · 2005
- Descendant · 3 generations on · 175 of its ownK052734 Modification to: Vertex Reconstruction SystemMedtronic Sofamor Danek · 2005
- Descendant · 3 generations on · 151 of its ownK062879 Traverse Oct Spinal Fixation SystemMedtronic Sofamor Danek, Inc. · 2006
- Descendant · 3 generations on · 150 of its ownK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
Showing 5 of 186 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 186 · See all- K021009Octafix Occipital Cervical Plating SystemSpinal Concepts, Inc. · 2002 · cites it directly184descendants
- K052402Vertex Reconstruction SystemMedtronic Sofamor Danek · 2005 · 2 generations on180descendants
- K052734Modification to: Vertex Reconstruction SystemMedtronic Sofamor Danek · 2005 · 3 generations on175descendants
- K062879Traverse Oct Spinal Fixation SystemMedtronic Sofamor Danek, Inc. · 2006 · 3 generations on151descendants
- K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007 · 3 generations on150descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011969 | Synthes Cervifix System | Synthes (Usa) | 2001 | — |
| +1 | K021009 | Octafix Occipital Cervical Plating System | Spinal Concepts, Inc. | 2002 | — |
| +2 | K052402 | Vertex Reconstruction System | Medtronic Sofamor Danek | 2005 | — |
| +3 | K052734 | Modification to: Vertex Reconstruction System | Medtronic Sofamor Danek | 2005 | — |
| +3 | K062879 | Traverse Oct Spinal Fixation System | Medtronic Sofamor Danek, Inc. | 2006 | — |
| +3 | K070742 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 4 | 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?
The FDA summary names no predicate by number.
What descends from it? (186)
See all 1863 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?
- Of its descendants, K021009 (Spinal Concepts, Inc., 2002) has gone furthest, with 184 descendants of its own.
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?
Hooks, Plate/Rods, Rods and Screws When intended to promote fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex) components of the Synthes CerviFix™ System are indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) spondylolisthesis spinal stenosis fracture/dislocation atlantoaxial…
Read the full statement (239 words)
Hooks, Plate/Rods, Rods and Screws
When intended to promote fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex) components of the Synthes CerviFix™ System are indicated for the following:
DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
spondylolisthesis
spinal stenosis
fracture/dislocation
atlantoaxial fracture with instability
occipitocervical dislocation
revision of previous cervical spine surgery
tumors
When used to treat these cervical and occipitocervical conditions, these screws are limited to occipital fixation only.
Hooks and Rods
The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Rods, Clamps, Screws and Nuts
The rods, clamps, screws and nuts are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3).
The use of these screws (3.5 mm, 4.0 mm cancellous and 3.5 mm, 4.2 mm cortex) is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.
The Synthes CerviFix™ System can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm parallel connectors from that system, and via the CerviFix tapered rods using lamina hooks, transverse process hooks, pedicle hooks, 4.2 mm screws, and the 5.0 mm/ 6.0 mm parallel connector.
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/K011969 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011969: Synthes Cervifix System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011969
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026