510(k) · Cleared
ClearedSintea Biotech Anterior Plate System, Model Acp.XX.T5.X
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sintea Biotech, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Sep 16, 2004 as substantially equivalent to K000742 (Synthes Spine, 2000) and 1 other predicate after a 55-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Sep 16, 2004
- Review
- 55 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K000536 (2000). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK000536 Synthes Anterior CSLP SystemSynthes Spine · 2000 · Recalled
- This deviceK041989 Sintea Biotech Anterior Plate System, Model Acp.XX.T5.XSintea Biotech, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK112861 Sintea Plustek Anterior Cervical Plate SystemSintea Plustek, LLC · 2012
Most influential descendants
Showing 1 of 1 · See all- K112861Sintea Plustek Anterior Cervical Plate SystemSintea Plustek, LLC · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000536 | Synthes Anterior CSLP System | Synthes Spine | 2000 | 1 |
| 0 (this device) | K041989 | Sintea Biotech Anterior Plate System, Model Acp.XX.T5.X | Sintea Biotech, Inc. | 2004 | — |
| +1 | K112861 | Sintea Plustek Anterior Cervical Plate System | Sintea Plustek, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K000742 | Synthes Anterior CSLP SystemSummary page 2…System is substantially equivalent to Synthes' Cervical Spine Locking Plate (CSLP), K000742 and K000536, (Decision Dates: 03/29/2000 and 03/15/2000, respectively). A basic feature comparison table for the Sintea Biotech A… | 2000 |
| * | K000536 | Synthes Anterior CSLP SystemSummary page 2…is substantially equivalent to Synthes' Cervical Spine Locking Plate (CSLP), K000742 and K000536, (Decision Dates: 03/29/2000 and 03/15/2000, respectively). A basic feature comparison table for the Sintea Biotech Anterior Cerv… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112861 | Sintea Plustek Anterior Cervical Plate System | 2012 | 0 |
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?
The Sintea Biotech Anterior Cervical Plate System is indicated for use in the cervical spine (levels C3 to C7) in the following conditions:
* Degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
* Spondylolisthesis
* Trauma (fracture or dislocation)
* Spinal stenosis
* Deformities or curvature (scoliosis, kyphosis, lordosis)
* Tumor
* Pseudarthrosis
* Failed previous fusion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041989 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041989: Sintea Biotech Anterior Plate System, Model Acp.XX.T5.X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041989
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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