510(k) · Cleared
ClearedThe Tosca Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Signus Medizintechnik GmbH · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Nov 23, 2004 as substantially equivalent to K990005 (Spinal Concepts, Inc., 1999) and 1 other predicate after a 15-day review. Its family tree reaches back 2 generations to 1992. 3 later devices descend from it.
- Decided
- Nov 23, 2004
- Review
- 15 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K922087 (1992). 6 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 1 generation backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
- This deviceK043082 The Tosca Anterior Cervical Plate SystemSignus Medizintechnik GmbH · 2004
- Descendant · cites it directly · 1 of its ownK153042 TRYPTIK2C-plate Anterior Cervical Plate SystemSpineart · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK171797 TRYPTIK2 C-Plate Anterior Cervical Plate SystemSpineart · 2018
- Descendant · cites it directly · 0 of its ownK132310 ASCOTBackroads Consulting, Inc. · 2013
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922087 | Anterior Cervical Plate System | Sofamor Danek Mfg., Inc. | 1992 | — |
| −1 | K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System | Spinal Concepts, Inc. | 1999 | 1 |
| 0 (this device) | K043082 | The Tosca Anterior Cervical Plate System | Signus Medizintechnik GmbH | 2004 | — |
| +1 | K153042 | TRYPTIK2C-plate Anterior Cervical Plate System | Spineart | 2016 | 7 |
| +2 | K171797 | TRYPTIK2 C-Plate Anterior Cervical Plate System | Spineart | 2018 | — |
| +1 | K132310 | ASCOT | Backroads Consulting, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSummary page 1…uct Code: KWQ Predicate IDevice(s): The subject device is equivalent to the following devices: * The SCI Anterior Cervical Plate System (K990005), manufactured by Spinal Concepts, Inc.; and * The EBI Anterior Plate Syste… | 1999 |
| * | K943694 | Ebi Anterior Cervical Spine SystemSummary page 1…terior Cervical Plate System (K990005), manufactured by Spinal Concepts, Inc.; and * The EBI Anterior Plate System (K943694 - K02980) Manufactured by EBI, L.P. Device Description: The TOSCAO Anterior Cervical Plate System c… | 1995 |
| Kept off the family tree | K020980 | FDA’s K020980 is Dimension Tpsa Calibrator, Model #RC459 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2002 |
What descends from it? (3)
2 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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K153042 (Spineart, 2016) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K990005.
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 TOSCA®Anterior Cervical Plate System is intended for anterior cervical fixation for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, and trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043082 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043082: The Tosca Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043082
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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