510(k) · Cleared
Recalled · 2008Modification to Cyclone Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Medical L.P. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on May 6, 2004 as substantially equivalent to K031214 (Encore Medical L.P., 2003) after a 79-day review. Its family tree reaches back 4 generations to 1993. It has been recalled 32 times.
- Decided
- May 6, 2004
- Review
- 79 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- 32
- Predicates
- 1
Its longest line of descent runs back 4 generations to K926453 (1993). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK926453 Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa) · 1993
- 3 generations backK971883 Synthes Spine Small Stature Anterior Cervical Vertebrae Plate SystemSynthes (Usa) · 1997 · Recalled
- 2 generations backK022344 Trinica Select Anterior Cervical Plate SystemCenterpulse Spine-Tech, Inc. · 2002 · Recalled
- 1 generation backK031214 Cyclone Anterior Cervical Plate SystemEncore Medical L.P. · 2003 · Recalled
- This deviceK040397 Modification to Cyclone Anterior Cervical Plate SystemEncore Medical L.P. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K926453 | Synthes (U.S.a.) Anterior Cervical Vertebrae Plate | Synthes (Usa) | 1993 | — |
| −3 | K971883 | Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System | Synthes (Usa) | 1997 | 1 |
| −2 | K022344 | Trinica Select Anterior Cervical Plate System | Centerpulse Spine-Tech, Inc. | 2002 | 1 |
| −1 | K031214 | Cyclone Anterior Cervical Plate System | Encore Medical L.P. | 2003 | 32 |
| 0 (this device) | K040397 | Modification to Cyclone Anterior Cervical Plate System | Encore Medical L.P. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 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 |
|---|---|---|---|
| * | K031214 | Cyclone Anterior Cervical Plate SystemSummary page 1…nce: The Cvcloner T Anterior Cervical Plate System is similar in design, indications and materials to Cyclone"' Anterior Cervical Plate System (K031214). DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 26, 2008 | Not classified | Z-1727-2008 | Device Design | The screw locking cap may fracture when the surgeon rotates it into the locked position. |
| Mar 26, 2008 | Not classified | Z-1747-2008 | Device Design | The screw locking cap may fracture when the surgeon rotates it into the locked position. |
| Mar 26, 2008 | Not classified | Z-1742-2008 | Device Design | The screw locking cap may fracture when the surgeon rotates it into the locked position. |
| Mar 26, 2008 | Not classified | Z-1721-2008 | Device Design | The screw locking cap may fracture when the surgeon rotates it into the locked position. |
| Mar 26, 2008 | Not classified | Z-1726-2008 | Device Design | The screw locking cap may fracture when the surgeon rotates it into the locked position. |
| Mar 26, 2008 | Not classified | Z-1738-2008 | Device Design | The screw locking cap may fracture when the surgeon rotates it into the locked position. |
| Mar 26, 2008 | Not classified | Z-1732-2008 | Device Design | The screw locking cap may fracture when the surgeon rotates it into the locked position. |
| Mar 26, 2008 | Not classified | Z-1728-2008 | Device Design | The screw locking cap may fracture when the surgeon rotates it into the locked position. |
| Mar 26, 2008 | Not classified | Z-1717-2008 | Device Design | The screw locking cap may fracture when the surgeon rotates it into the locked position. |
| Mar 26, 2008 | Not classified | Z-1718-2008 | Device Design | The screw locking cap may fracture when the surgeon rotates it into the locked position. |
| Mar 26, 2008 | Not classified | Z-1745-2008 | Device Design | The screw locking cap may fracture when the surgeon rotates it into the locked position. |
| Mar 26, 2008 | Not classified | Z-1730-2008 | Device Design | The screw locking cap may fracture when the surgeon rotates it into the locked position. |
| Mar 26, 2008 | Not classified | Z-1729-2008 | Device Design | The screw locking cap may fracture when the surgeon rotates it into the locked position. |
| Mar 26, 2008 | Not classified | Z-1734-2008 | Device Design | The screw locking cap may fracture when the surgeon rotates it into the locked position. |
| Mar 26, 2008 | Not classified | Z-1744-2008 | Device Design | The screw locking cap may fracture when the surgeon rotates it into the locked position. |
| Mar 26, 2008 | Not classified | Z-1740-2008 | Device Design | The screw locking cap may fracture when the surgeon rotates it into the locked position. |
| Mar 26, 2008 | Not classified | Z-1735-2008 | Device Design | The screw locking cap may fracture when the surgeon rotates it into the locked position. |
| Mar 26, 2008 | Not classified | Z-1741-2008 | Device Design | The screw locking cap may fracture when the surgeon rotates it into the locked position. |
| Mar 26, 2008 | Not classified | Z-1746-2008 | Device Design | The screw locking cap may fracture when the surgeon rotates it into the locked position. |
| Mar 26, 2008 | Not classified | Z-1748-2008 | Device Design | The screw locking cap may fracture when the surgeon rotates it into the locked position. |
| Mar 26, 2008 | Not classified | Z-1739-2008 | Device Design | The screw locking cap may fracture when the surgeon rotates it into the locked position. |
| Mar 26, 2008 | Not classified | Z-1743-2008 | Device Design | The screw locking cap may fracture when the surgeon rotates it into the locked position. |
| Mar 26, 2008 | Not classified | Z-1733-2008 | Device Design | The screw locking cap may fracture when the surgeon rotates it into the locked position. |
| Mar 26, 2008 | Not classified | Z-1737-2008 | Device Design | The screw locking cap may fracture when the surgeon rotates it into the locked position. |
| Mar 26, 2008 | Not classified | Z-1719-2008 | Device Design | The screw locking cap may fracture when the surgeon rotates it into the locked position. |
| Mar 26, 2008 | Not classified | Z-1731-2008 | Device Design | The screw locking cap may fracture when the surgeon rotates it into the locked position. |
| Mar 26, 2008 | Not classified | Z-1725-2008 | Device Design | The screw locking cap may fracture when the surgeon rotates it into the locked position. |
| Mar 26, 2008 | Not classified | Z-1722-2008 | Device Design | The screw locking cap may fracture when the surgeon rotates it into the locked position. |
| Mar 26, 2008 | Not classified | Z-1736-2008 | Device Design | The screw locking cap may fracture when the surgeon rotates it into the locked position. |
| Mar 26, 2008 | Not classified | Z-1723-2008 | Device Design | The screw locking cap may fracture when the surgeon rotates it into the locked position. |
| Mar 26, 2008 | Not classified | Z-1720-2008 | Device Design | The screw locking cap may fracture when the surgeon rotates it into the locked position. |
| Mar 26, 2008 | Not classified | Z-1724-2008 | Device Design | The screw locking cap may fracture when the surgeon rotates it into the locked position. |
The 5 latest of 32 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 3 of the 8 ancestors have a recall of any class.
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 Cyclone TM Anterior Cervical Plate is a unilateral fixation device intended to provide stabilization during the process of cervical spinal fusion (C2-C7) in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040397 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040397: Modification to Cyclone Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040397
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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