510(k) · Cleared
Recalled · 2011Manta Ray Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theken Spine, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Apr 25, 2008 as substantially equivalent to K052292 (X-Spine Systems, Inc., 2005) and 1 other predicate after a 45-day review. Its family tree reaches back 3 generations to 1993. It has been recalled 2 times.
- Decided
- Apr 25, 2008
- Review
- 45 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 3 generations to K926453 (1993). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK926453 Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa) · 1993
- 2 generations backK970048 Synthes (Usa)Titanium Locking Plate System (Tilps)Synthes (Usa) · 1997
- 1 generation backK010466 Tether AcfsTheken Surgical,Llc · 2001
- This deviceK080690 Manta Ray Anterior Cervical Plate SystemTheken Spine, LLC · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K926453 | Synthes (U.S.a.) Anterior Cervical Vertebrae Plate | Synthes (Usa) | 1993 | — |
| −2 | K970048 | Synthes (Usa)Titanium Locking Plate System (Tilps) | Synthes (Usa) | 1997 | — |
| −1 | K010466 | Tether Acfs | Theken Surgical,Llc | 2001 | — |
| 0 (this device) | K080690 | Manta Ray Anterior Cervical Plate System | Theken Spine, LLC | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K052292 | Spider Cervical Plating (SCP) SystemSummary page 1…stiffness, strength and fatigue life of Manta Ray ACP System Predicate Device: X-Spine Systems - Spider Cervical Plating System (K052292 - October 21, 2005) Theken Surgical, LLC - TetherTm ACFS (K010466… | 2005 |
| * | K010466 | Tether AcfsSummary page 1…stems - Spider Cervical Plating System (K052292 - October 21, 2005) Theken Surgical, LLC - TetherTm ACFS (K010466 - May 16, 2001) C. Substantial Equivalence Theken Spine, LLC believes that the Manta RayTm… | 2001 |
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 |
|---|---|---|---|---|
| Jan 10, 2011 | Not classified | Z-2197-2011 | Pending | Based upon the results of the firm's literature review, they determined that the Package Insert (Information for Use) and information in the Surgical Technique should be revised to include additional warnings, precautions and possible… |
| Jul 29, 2010 | Not classified | Z-0087-2011 | Other | The Manta Ray Cervical System was subject to corrective action by the firm after two (2) customer complaints were received alleging that screws were 'backing out' of the device during surgical procedures. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- None of the 6 ancestors has a recall.
- 14 other devices also cite its predicate K052292.
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. 2008, this device’s year, is highlighted.
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 Manta Ray TM ACP System is an anterior cervical plate that is intended for temporary stabilization of the cervical spine from C2-C7 due to the following indications:
Degenerative Disc Disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
Spondylolisthesis
Trauma (i.e. fracture/dislocation)
Tumor
Spinal stenosis
Deformity (i.e. scoliosis, kyphosis and/or lordosis)
Pseudoarthrosis
Failed previous fusion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080690 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080690: Manta Ray 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/K080690
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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