510(k) · Cleared
ClearedSynthes Anterior Cervical Compression System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Feb 5, 2004 as substantially equivalent to K031276 (Synthes (Usa), 2003) after a 56-day review. Its family tree reaches back 1 generation to 2003. 91 later devices descend from it.
- Decided
- Feb 5, 2004
- Review
- 56 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K031276 (2003). 91 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK031276 Synthes Anterior Cervical Locking Plate (Aclp) SystemSynthes (Usa) · 2003
- This deviceK033844 Synthes Anterior Cervical Compression SystemSynthes (Usa) · 2004
- Descendant · cites it directly · 84 of its ownK050451 Synthes Vectra SystemSynthes Spine Co.Lp · 2005 · Recalled
- Descendant · 2 generations on · 49 of its ownK051665 Synthes Vectra-T SystemSynthes Spine · 2005 · Recalled
- Descendant · 2 generations on · 33 of its ownK112068 Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp · 2011 · Recalled
- Descendant · 3 generations on · 30 of its ownK121852 Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp · 2012
- Descendant · 2 generations on · 26 of its ownK071667 Synthes Vectra-One SystemSynthes Spine · 2007 · Recalled
Showing 5 of 91 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 91 · See all- K050451Synthes Vectra SystemSynthes Spine Co.Lp · 2005 · cites it directly84descendants
- K051665Synthes Vectra-T SystemSynthes Spine · 2005 · 2 generations on49descendants
- K112068Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp · 2011 · 2 generations on33descendants
- K121852Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp · 2012 · 3 generations on30descendants
- K071667Synthes Vectra-One SystemSynthes Spine · 2007 · 2 generations on26descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031276 | Synthes Anterior Cervical Locking Plate (Aclp) System | Synthes (Usa) | 2003 | — |
| 0 (this device) | K033844 | Synthes Anterior Cervical Compression System | Synthes (Usa) | 2004 | — |
| +1 | K050451 | Synthes Vectra System | Synthes Spine Co.Lp | 2005 | 3 |
| +2 | K051665 | Synthes Vectra-T System | Synthes Spine | 2005 | 2 |
| +2 | K112068 | Synthes Zero-P Variable Angle (VA) | Synthes Spine Co.Lp | 2011 | 1 |
| +3 | K121852 | Synthes Zero-P Variable Angle (VA) | Synthes Spine Co.Lp | 2012 | — |
| +2 | K071667 | Synthes Vectra-One System | Synthes Spine | 2007 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2018 | 6 | 0 |
| 2019 | 6 | 0 |
| 2020 | 4 | 0 |
| 2021 | 6 | 0 |
| 2022 | 6 | 0 |
| 2023 | 9 | 0 |
| 2024 | 10 | 0 |
| 2025 | 6 | 0 |
| 2026 | 6 | 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 KWQ? 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? (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 |
|---|---|---|---|
| * | K031276 | Synthes Anterior Cervical Locking Plate (Aclp) SystemSummary page 1…[email protected] Name of the Device Synthes Anterior Cervical Compression System Predicate Device Synthes Anterior Cervical Locking Plate - K031276 Device Description The Synthes Anterior Cervical Compression System consists of plates with cortical… | 2003 |
What descends from it? (91)
See all 912 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 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 | — |
What is it indicated for?
Synthes Anterior Cervical Compression System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: Degenerative Disc Disease (DDD), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions, pseudoarthosis, and deformity (defined as kyphosis, lordosis or scoliosis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033844 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033844: Synthes Anterior Cervical Compression System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033844
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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