510(k) · Cleared
ClearedSynthes Spine 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 Jan 21, 1999 after a 49-day review. The FDA summary names no predicate by number. 2 of the 673 devices in its family, counting itself, have a Class I recall. 672 later devices descend from it.
- Decided
- Jan 21, 1999
- Review
- 49 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 0
672 later devices descend from it, 4 citing it directly. 2 of the 673 devices in this family, counting this one, have a Class I recall.
- This deviceK984377 Synthes Spine Cervifix SystemSynthes (Usa) · 1999
- Descendant · cites it directly · 671 of its ownK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- Descendant · 2 generations on · 660 of its ownK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- Descendant · 2 generations on · 659 of its ownK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- Descendant · 2 generations on · 658 of its ownK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- Descendant · 2 generations on · 657 of its ownK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
Showing 5 of 672 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 672 · See all- K002733Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000 · cites it directly671descendants
- K013222Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001 · 2 generations on660descendants
- K022190Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002 · 2 generations on659descendants
- K030103Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003 · 2 generations on658descendants
- K041203Summit Oct Spinal SystemDepuy Spine, Inc. · 2004 · 2 generations on657descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K984377 | Synthes Spine Cervifix System | Synthes (Usa) | 1999 | — |
| +1 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| +2 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| +2 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| +2 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| +2 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 8 | 0 |
| 2008 | 14 | 0 |
| 2009 | 10 | 0 |
| 2010 | 13 | 1 |
| 2011 | 15 | 0 |
| 2012 | 29 | 0 |
| 2013 | 31 | 0 |
| 2014 | 31 | 0 |
| 2015 | 38 | 0 |
| 2016 | 29 | 0 |
| 2017 | 37 | 0 |
| 2018 | 38 | 0 |
| 2019 | 32 | 0 |
| 2020 | 38 | 0 |
| 2021 | 33 | 1 |
| 2022 | 38 | 0 |
| 2023 | 66 | 0 |
| 2024 | 57 | 0 |
| 2025 | 50 | 0 |
| 2026 | 49 | 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.
2 devices in this family have a Class I recall. 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? (672)
See all 6724 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- Of its descendants, K002733 (Depuyacromed, 2000) has gone furthest, with 671 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?
The CerviFix System is intended to provide stabilization to promote fusion of the cervical spine and occipital-cervical junction (occiput — T3) for the following indications:
DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
spondylolisthesis
spinal stenosis
fracture/dislocation
atlanto-axial fracture with instability
occipital-cervical dislocation
revision of previous cervical spine surgery
tumors
The screws are limited to occipital fixation only.
The CerviFix System can also be linked to the Synthes Posterior Universal Spine System using the 3.5/6.0mm parallel connectors from that system.
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/K984377 · printed Nov 5, 2026
Cite this page
510(k) Report. “K984377: Synthes Spine Cervifix System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K984377
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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