510(k) · Cleared
ClearedSkyway Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kyocera Medical Technologies Inc. (KMTI) · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Sep 12, 2023 as substantially equivalent to K221049 (Zavation Medical Products, LLC, 2022) and 4 other predicates after an 88-day review. Its family tree reaches back 25 generations to 1984. 1 of the 583 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Sep 12, 2023
- Review
- 88 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 25 generations to K841189 (1984). 579 ancestors in all, the oldest K792352 (1979). 3 later devices descend from it, 1 citing it directly. 1 of the 583 devices in this family, counting this one, has a Class I recall.
- Root · 25 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 21 generations between
- 3 generations backK191354 Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2019
- 2 generations backK202305 Zavation IBF SystemZavation Medical Products, LLC · 2020
- 1 generation backK221049 Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC · 2022
- This deviceK231766 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2023
- Descendant · cites it directly · 2 of its ownK243015 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK250486 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2025
- Descendant · 3 generations on · 0 of its ownK261451 ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026
Show all 25 generations
- Root · 25 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 24 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 23 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 22 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 21 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 20 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 19 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 18 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 17 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 16 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 15 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 14 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 13 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 12 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 11 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 10 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 9 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 8 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 7 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 6 generations backK160125 Cascadia Interbody SystemK2m · 2016
- 5 generations backK162264 Cascadia Interbody SystemK2m, Inc. · 2016
- 4 generations backK172941 CASCADIA Interbody SystemK2m · 2018
- 3 generations backK191354 Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2019
- 2 generations backK202305 Zavation IBF SystemZavation Medical Products, LLC · 2020
- 1 generation backK221049 Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC · 2022
- This deviceK231766 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2023
Class I recalls in this family
- K073202 Ardis Spacer7 generations back · 2008
Most influential descendants
Showing 3 of 3 · See all- K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc. · 2024 · cites it directly2descendants
- K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2025 · 2 generations on1descendant
- K261451ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −25 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −24 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −23 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −22 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −21 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −20 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −19 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −18 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −17 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −16 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −15 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −14 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −13 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −12 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −11 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −10 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −9 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −8 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −7 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −6 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| −5 | K162264 | Cascadia Interbody System | K2m, Inc. | 2016 | — |
| −4 | K172941 | CASCADIA Interbody System | K2m | 2018 | — |
| −3 | K191354 | Ti3Z Cervical Interbody System | Zavation Medical Products, LLC | 2019 | — |
| −2 | K202305 | Zavation IBF System | Zavation Medical Products, LLC | 2020 | — |
| −1 | K221049 | Zavation VariSync Plate System and VariSync Spacer System | Zavation Medical Products, LLC | 2022 | — |
| 0 (this device) | K231766 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | 2023 | — |
| +1 | K243015 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies, Inc. | 2024 | — |
| +2 | K250486 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | 2025 | — |
| +3 | K261451 | ZSAlign Cervical Interbody System | ZSFab, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 7 | 0 |
| 1997 | 5 | 0 |
| 1998 | 5 | 0 |
| 1999 | 8 | 0 |
| 2000 | 12 | 0 |
| 2001 | 17 | 0 |
| 2002 | 16 | 0 |
| 2003 | 22 | 0 |
| 2004 | 35 | 0 |
| 2005 | 31 | 0 |
| 2006 | 22 | 0 |
| 2007 | 24 | 0 |
| 2008 | 55 | 1 |
| 2009 | 42 | 0 |
| 2010 | 32 | 0 |
| 2011 | 46 | 0 |
| 2012 | 29 | 0 |
| 2013 | 26 | 0 |
| 2014 | 37 | 0 |
| 2015 | 18 | 0 |
| 2016 | 21 | 0 |
| 2017 | 12 | 0 |
| 2018 | 5 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
1 device in this family has a Class I recall. 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? (5)
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 |
|---|---|---|---|
| * | K221049 | Zavation VariSync Plate System and VariSync Spacer SystemSummary page 5…Product Code Predicate Number Type K221049 VariSync Plate System Zavation Medical Products, LLC OVE, ODP, KWQ Primary K141993 Na… | 2022 |
| * | K141993 | Nakoma AcpSummary page 5…Type K221049 VariSync Plate System Zavation Medical Products, LLC OVE, ODP, KWQ Primary K141993 Nakoma ACP System Alliance Partners, LLC KWQ Additional K060025… | 2014 |
| * | K060025 | Slimplicity Anterior Cervical Plate SystemSummary page 5…cts, LLC OVE, ODP, KWQ Primary K141993 Nakoma ACP System Alliance Partners, LLC KWQ Additional K060025 Slimplicity Anterior Cervical Plate System Spinal USA (now Precision Spine) KWQ Additional K152193… | 2006 |
| * | K152193 | Renovis Anterior Cervical Plate SystemSummary page 5…KWQ Additional K060025 Slimplicity Anterior Cervical Plate System Spinal USA (now Precision Spine) KWQ Additional K152193 Renovis Anterior Cervical Plate System Renovis Surgical Technologies, Inc. KWQ Additional K223105… | 2015 |
| * | K223105 | Tesera-K SC SystemSummary page 5…Spine) KWQ Additional K152193 Renovis Anterior Cervical Plate System Renovis Surgical Technologies, Inc. KWQ Additional K223105 Tesera-K SC System Kyocera Medical Technologies, Inc. OVE, ODP Additional PERFORMANC… | 2022 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243015 | Skyway Anterior Cervical Plate System | 2024 | 2 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 7 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 39 years and passes through 16 companies; a new generation was cleared every 11 months on median.
- 67 of the 579 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K243015 (Kyocera Medical Technologies, Inc., 2024) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K221049.
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. 2023, 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 Skyway Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations)…
Read the full statement (188 words)
The Skyway Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis, or scoliosis), tumor, pseudarthrosis or failed previous fusion.
The 4-Hole 1-Level Plates are limited to use at one contiguous level.
The KMTI Tesera-K SC System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one or two levels from C2-T1. KMTI Tesera-K SC System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation. When used with the Skyway Anterior Cervical Plate System plates designed with spacer attachment, the assembly takes on the indications of the KMTI Tesera-K SC lnterbody Spacer, with the Skyway Anterior Cervical Plate System acting as the supplemental fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231766 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231766: Skyway 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/K231766
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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