510(k) · Cleared
Recalled · Class II · 2021CervAlign™ Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jan 17, 2019 as substantially equivalent to K130427 (Pioneer Surgical Technology, Inc., 2013) and 1 other predicate after a 76-day review. Its family tree reaches back 9 generations to 1992. 2 later devices descend from it. It has been recalled once.
- Decided
- Jan 17, 2019
- Review
- 76 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 9 generations to K922087 (1992). 34 ancestors in all, the oldest K831246 (1983). 2 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 5 generations between
- 3 generations backK100708 Pioneer Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology · 2010
- 2 generations backK111528 Pioneer Aspect Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology, Inc. · 2011
- 1 generation backK130427 Pioneer Aspect Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. · 2013
- This deviceK183060 CervAlign™ Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2019
- Descendant · cites it directly · 1 of its ownK211408 CervAlign® Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK251436 Resolve Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. · 2025
Show all 9 generations
- Root · 9 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 8 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
- 7 generations backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
- 6 generations backK043066 Pioneer Anterior Cervical Plate SystemPioneer Surgical Technology · 2005
- 5 generations backK053053 Pacp SystemPioneer Surgical Technology · 2005
- 4 generations backK072703 Pioneer Slimfuse Anterior Cervical Plating SystemPioneer Surgical Technology · 2008
- 3 generations backK100708 Pioneer Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology · 2010
- 2 generations backK111528 Pioneer Aspect Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology, Inc. · 2011
- 1 generation backK130427 Pioneer Aspect Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. · 2013
- This deviceK183060 CervAlign™ Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K922087 | Anterior Cervical Plate System | Sofamor Danek Mfg., Inc. | 1992 | — |
| −8 | K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System | Spinal Concepts, Inc. | 1999 | 1 |
| −7 | K000486 | Abc Cervical Plating System | Aesculap, Inc. | 2000 | — |
| −6 | K043066 | Pioneer Anterior Cervical Plate System | Pioneer Surgical Technology | 2005 | — |
| −5 | K053053 | Pacp System | Pioneer Surgical Technology | 2005 | — |
| −4 | K072703 | Pioneer Slimfuse Anterior Cervical Plating System | Pioneer Surgical Technology | 2008 | — |
| −3 | K100708 | Pioneer Anterior Cervical Plate Model 24-Series | Pioneer Surgical Technology | 2010 | — |
| −2 | K111528 | Pioneer Aspect Anterior Cervical Plate Model 24-Series | Pioneer Surgical Technology, Inc. | 2011 | — |
| −1 | K130427 | Pioneer Aspect Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. | 2013 | — |
| 0 (this device) | K183060 | CervAlign™ Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2019 | — |
| +1 | K211408 | CervAlign® Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. | 2021 | — |
| +2 | K251436 | Resolve Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K130427 | Pioneer Aspect Anterior Cervical Plate SystemSummary page 4…Intervertebral Body) Panel: Orthopedic Device Panel Predicates: Primary Predicate: Pioneer Aspect Anterior Cervical Plate System (K130427 cleared 6/5/2013)- Pioneer Surgical Technology, Inc. Additional Predicate:… | 2013 |
| * | K083663 | PACPSummary page 4…cleared 6/5/2013)- Pioneer Surgical Technology, Inc. Additional Predicate: Pioneer Anterior Cervical Plate System (PACP) (K083663 cleared 2/25/2009)- Pioneer Surgical Technology, Inc. Description: The CervAlign Anterior Cervical Plate… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211408 | CervAlign® Anterior Cervical Plate System | 2021 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 15, 2021 | Class II | Z-1218-2021 | Under Investigation by firm | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision |
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 2.1 years on median.
- 5 of the 34 ancestors have a recall of any class.
- Of its descendants, K211408 (Pioneer Surgical Technology, Inc., 2021) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K130427.
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 CervAlign Anterior Cervical Plate System is intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion.
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/K183060 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183060: CervAlign™ 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/K183060
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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