510(k) · Cleared
ClearedSimal Cervical Stabilization System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Top Surgical Products GmbH · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on May 27, 1998 as substantially equivalent to K953720 (Aesculap, Inc., 1995) and 2 other predicates after a 70-day review. Its family tree reaches back 1 generation to 1979.
- Decided
- May 27, 1998
- Review
- 70 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K792352 (1979). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK792352 Synthes Cervical Vertabrae PlatesDePuy Synthes · 1979
- This deviceK981008 Simal Cervical Stabilization SystemTop Surgical Products GmbH · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K792352 | Synthes Cervical Vertabrae Plates | DePuy Synthes | 1979 | — |
| 0 (this device) | K981008 | Simal Cervical Stabilization System | Top Surgical Products GmbH | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K953720 | Aesculap Caspar Plate & Screw System for Anterior Cervical FusionSummary page 1…alence. The devices in consideration are substantially equivalent to the devices currently marketed by Aesculap, Caspar Anterior Cervical Fusion Instrumentation System, K953720; Synthes Anterior Cervical Vertebrate Plate System, K845700; and Synthes Cervical Vertebrate Plates, K792352. A Teleriex Compin,… | 1995 |
| * | K945700 | Synthes (Usa) Anterior Cervical Vertebrae Plate System Our OCR of the scanned summary read K845700, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Synthes Anterior Cervical Vertebrate Plate System”. | 1995 |
| * | K792352 | Synthes Cervical Vertabrae PlatesSummary page 1…lap, Caspar Anterior Cervical Fusion Instrumentation System, K953720; Synthes Anterior Cervical Vertebrate Plate System, K845700; and Synthes Cervical Vertebrate Plates, K792352. A Teleriex Compin, One Weck Drive, PO. Box 12600 Research Triangle Park, North Carolina 27709 {819) 544-8000 p… | 1979 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K953720.
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 TSP Cervical Stabilization System is intended for anterior screw fixation to the cervical spine. Fixation is done via ventral or transoral approach.
Spondylolisthesis (instability)
Fractures
Spinal Stenosis.
Deformities (Scholiosis, Kyphosis, Lordosis)
Tumors
Pseudarthrosis
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/K981008 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981008: Simal Cervical Stabilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981008
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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