510(k) · Cleared
ClearedSynthes Cervifix System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes Spine · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jul 20, 2000 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 734 devices in its family, counting itself, have a Class I recall. 733 later devices descend from it.
- Decided
- Jul 20, 2000
- Review
- 30 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
733 later devices descend from it, 4 citing it directly. 3 of the 734 devices in this family, counting this one, have a Class I recall.
- This deviceK001864 Synthes Cervifix SystemSynthes Spine · 2000
- Descendant · cites it directly · 671 of its ownK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- Descendant · cites it directly · 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 733 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 733 · See all- K002733Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000 · cites it directly671descendants
- K013222Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001 · cites it directly660descendants
- 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) | K001864 | Synthes Cervifix System | Synthes Spine | 2000 | — |
| +1 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| +1 | 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 | 5 | 0 |
| 2007 | 9 | 0 |
| 2008 | 16 | 0 |
| 2009 | 10 | 0 |
| 2010 | 15 | 2 |
| 2011 | 17 | 0 |
| 2012 | 35 | 0 |
| 2013 | 35 | 0 |
| 2014 | 37 | 0 |
| 2015 | 42 | 0 |
| 2016 | 36 | 0 |
| 2017 | 42 | 0 |
| 2018 | 43 | 0 |
| 2019 | 33 | 0 |
| 2020 | 42 | 0 |
| 2021 | 36 | 1 |
| 2022 | 39 | 0 |
| 2023 | 69 | 0 |
| 2024 | 59 | 0 |
| 2025 | 50 | 0 |
| 2026 | 51 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 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.
Top candidate predicates for a new KWQ device
- #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (733)
See all 7334 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 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.
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
- K093670Modification to: Oasys SystemStryker Spine · 2010 · 4 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
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 KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, 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 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
https://510kreport.com/device/K001864 · printed Nov 5, 2026
Cite this page
510(k) Report. “K001864: Synthes 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/K001864
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026