510(k) · Cleared
ClearedDogbone Acfs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theken Surgical · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Feb 4, 2000 as substantially equivalent to K970048 (Synthes (Usa), 1997) after a 38-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Feb 4, 2000
- Review
- 38 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K926453 (1993). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K926453 | Synthes (U.S.a.) Anterior Cervical Vertebrae Plate | Synthes (Usa) | 1993 | — |
| −1 | K970048 | Synthes (Usa)Titanium Locking Plate System (Tilps) | Synthes (Usa) | 1997 | — |
| 0 (this device) | K994383 | Dogbone Acfs | Theken Surgical | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 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? (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 |
|---|---|---|---|
| * | K970048 | Synthes (Usa)Titanium Locking Plate System (Tilps)Summary page 1…mployed as an internal fixation device during the time interval required for arthrodesis. Substantial Equivalence: Synthes (USA) Titanium Locking Plate System (TILPS) (K970048) 3¢ l'lQ‘. o %, _/@ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration FE… | 1997 |
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?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
- None of the 4 ancestors has a recall.
- 6 other devices also cite its predicate K970048.
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 Dogbone ACFS is indicated for trauma, deformity (tordosis and kyphosis), pseudoarthrosis, previously failed cervical spine fusion, tumor, degenerative disk disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.), and spinal canal stenaosis.
The Dogbone ACFS is indicated for stabilizing the spine from C2 to C7. Unicortical or bicortical fixation from the anterior face of the vertebral bodies may be employed using either the variable angle or fixed angle screws. This producl may be employed as an internal fixation device during the time interval required for arthrodesis.
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/K994383 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994383: Dogbone Acfs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994383
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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