510(k) · Cleared
ClearedAthena II Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medyssey USA, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Feb 11, 2019 as substantially equivalent to K180022 (Medyssey USA, Inc., 2018) and 2 other predicates after a 63-day review. Its family tree reaches back 11 generations to 1992. 1 later device descends from it.
- Decided
- Feb 11, 2019
- Review
- 63 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K922087 (1992). 36 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 7 generations between
- 3 generations backK062110 Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2006
- 2 generations backK081567 Vertebron SSP Cervical Plating SystemVertebron, Inc. · 2008
- 1 generation backK180022 Athena Cervical Plate SystemMedyssey USA, Inc. · 2018
- This deviceK183409 Athena II Cervical Plate SystemMedyssey USA, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK230301 Athena III Cervical Plate SystemMedyssey USA, Inc. · 2023
Show all 11 generations
- Root · 11 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 10 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
- 9 generations backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
- 8 generations backK012184 Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2002
- 7 generations backK030595 Blackstone Fusion Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2003
- 6 generations backK040003 Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2004
- 5 generations backK043181 Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2004
- 4 generations backK051815 Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2005
- 3 generations backK062110 Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2006
- 2 generations backK081567 Vertebron SSP Cervical Plating SystemVertebron, Inc. · 2008
- 1 generation backK180022 Athena Cervical Plate SystemMedyssey USA, Inc. · 2018
- This deviceK183409 Athena II Cervical Plate SystemMedyssey USA, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K230301Athena III Cervical Plate SystemMedyssey USA, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K922087 | Anterior Cervical Plate System | Sofamor Danek Mfg., Inc. | 1992 | — |
| −10 | K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System | Spinal Concepts, Inc. | 1999 | 1 |
| −9 | K000486 | Abc Cervical Plating System | Aesculap, Inc. | 2000 | — |
| −8 | K012184 | Blackstone Iii Anterior Cervical Plating System | Blackstone Medical, Inc. | 2002 | — |
| −7 | K030595 | Blackstone Fusion Anterior Cervical Plating System | Blackstone Medical, Inc. | 2003 | — |
| −6 | K040003 | Vertebron SCP Cervical Plate System | Vertebron, Inc. | 2004 | — |
| −5 | K043181 | Modification to Vertebron SCP Cervical Plate System | Vertebron, Inc. | 2004 | — |
| −4 | K051815 | Modification to Vertebron SCP Cervical Plate System | Vertebron, Inc. | 2005 | — |
| −3 | K062110 | Vertebron SCP Cervical Plate System | Vertebron, Inc. | 2006 | — |
| −2 | K081567 | Vertebron SSP Cervical Plating System | Vertebron, Inc. | 2008 | — |
| −1 | K180022 | Athena Cervical Plate System | Medyssey USA, Inc. | 2018 | — |
| 0 (this device) | K183409 | Athena II Cervical Plate System | Medyssey USA, Inc. | 2019 | — |
| +1 | K230301 | Athena III Cervical Plate System | Medyssey USA, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K180022 | Athena Cervical Plate SystemSummary page 4…ystem can be implanted in the sub-axial cervical spine from C3 through C7 levels. Predicate Device(s): The primary predicate device is the Athena Cervical Plate System (K180022). Additional predicate devices include the Vertebron Cervical Plate (K081567) and the Vectra Cervical Plate System (K050451). ==… | 2018 |
| * | K081567 | Vertebron SSP Cervical Plating SystemSummary page 4…els. Predicate Device(s): The primary predicate device is the Athena Cervical Plate System (K180022). Additional predicate devices include the Vertebron Cervical Plate (K081567) and the Vectra Cervical Plate System (K050451).… | 2008 |
| * | K050451 | Synthes Vectra SystemSummary page 4…e device is the Athena Cervical Plate System (K180022). Additional predicate devices include the Vertebron Cervical Plate (K081567) and the Vectra Cervical Plate System (K050451). K183409 - Page 2 of 2… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230301 | Athena III Cervical Plate System | 2023 | 0 |
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 27 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 36 ancestors have a recall of any class.
- Of its descendants, K230301 (Medyssey USA, Inc., 2023) has gone furthest, with 0 descendants of its own.
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. 2019, 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 Athena II Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of a solid spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration 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. The Athena II Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183409 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183409: Athena II 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/K183409
Report an extraction error
Are you the manufacturer?
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