510(k) · Cleared
ClearedPioneer Aspect 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. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jun 5, 2013 as substantially equivalent to K111528 (Pioneer Surgical Technology, Inc., 2011) and 5 other predicates after a 105-day review. Its family tree reaches back 8 generations to 1992. 5 later devices descend from it.
- Decided
- Jun 5, 2013
- Review
- 105 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 8 generations to K922087 (1992). 33 ancestors in all, the oldest K831246 (1983). 5 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 7 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
- 6 generations backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
- 5 generations backK043066 Pioneer Anterior Cervical Plate SystemPioneer Surgical Technology · 2005
- 4 generations backK053053 Pacp SystemPioneer Surgical Technology · 2005
- 3 generations backK072703 Pioneer Slimfuse Anterior Cervical Plating SystemPioneer Surgical Technology · 2008
- 2 generations backK100708 Pioneer Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology · 2010
- 1 generation backK111528 Pioneer Aspect Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology, Inc. · 2011
- This deviceK130427 Pioneer Aspect Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK183060 CervAlign™ Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2019 · Recalled
- Descendant · 2 generations on · 1 of its ownK211408 CervAlign® Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK133245 Genesys Spine Anterior Cervical Plate II SystemGenesys Spine · 2014 · Recalled
- Descendant · 3 generations on · 0 of its ownK251436 Resolve Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK192076 Binary® Anterior Cervical Plate SystemGenesys Spine · 2019
Most influential descendants
Showing 5 of 5 · See all- K183060CervAlign™ Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2019 · cites it directly2descendants
- K211408CervAlign® Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. · 2021 · 2 generations on1descendant
- K133245Genesys Spine Anterior Cervical Plate II SystemGenesys Spine · 2014 · cites it directly1descendant
- K251436Resolve Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. · 2025 · 3 generations on0descendants
- K192076Binary® Anterior Cervical Plate SystemGenesys Spine · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K922087 | Anterior Cervical Plate System | Sofamor Danek Mfg., Inc. | 1992 | — |
| −7 | K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System | Spinal Concepts, Inc. | 1999 | 1 |
| −6 | K000486 | Abc Cervical Plating System | Aesculap, Inc. | 2000 | — |
| −5 | K043066 | Pioneer Anterior Cervical Plate System | Pioneer Surgical Technology | 2005 | — |
| −4 | K053053 | Pacp System | Pioneer Surgical Technology | 2005 | — |
| −3 | K072703 | Pioneer Slimfuse Anterior Cervical Plating System | Pioneer Surgical Technology | 2008 | — |
| −2 | K100708 | Pioneer Anterior Cervical Plate Model 24-Series | Pioneer Surgical Technology | 2010 | — |
| −1 | K111528 | Pioneer Aspect Anterior Cervical Plate Model 24-Series | Pioneer Surgical Technology, Inc. | 2011 | — |
| 0 (this device) | K130427 | Pioneer Aspect Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. | 2013 | — |
| +1 | K183060 | CervAlign™ Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2019 | 1 |
| +2 | K211408 | CervAlign® Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. | 2021 | — |
| +1 | K133245 | Genesys Spine Anterior Cervical Plate II System | Genesys Spine | 2014 | 1 |
| +3 | K251436 | Resolve Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. | 2025 | — |
| +2 | K192076 | Binary® Anterior Cervical Plate System | Genesys Spine | 2019 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2019 | 2 | 0 |
| 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? (6)
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 |
|---|---|---|---|
| * | K111528 | Pioneer Aspect Anterior Cervical Plate Model 24-SeriesSummary page 2…parison to Predicate Devices Performance and SE . Determination: The Sponsor is claiming substantial equivalence to the following legally marketed predicate devices: K111528 Pioneer Aspect Anterior Cervical Plate System (24-series, SE 8/24/11) K100708 Pioneer Anterior Cervical Plate System (SE 6/4/10)… | 2011 |
| * | K100708 | Pioneer Anterior Cervical Plate Model 24-SeriesSummary page 2…is claiming substantial equivalence to the following legally marketed predicate devices: K111528 Pioneer Aspect Anterior Cervical Plate System (24-series, SE 8/24/11) K100708 Pioneer Anterior Cervical Plate System (SE 6/4/10) K083663 Pioneer PACP (SE 2/25/09) K971883 Synthes Spine Small Stature Anteri… | 2010 |
| * | K083663 | PACPSummary page 2…y marketed predicate devices: K111528 Pioneer Aspect Anterior Cervical Plate System (24-series, SE 8/24/11) K100708 Pioneer Anterior Cervical Plate System (SE 6/4/10) K083663 Pioneer PACP (SE 2/25/09) K971883 Synthes Spine Small Stature Anterior Cervical Plate System (SE 10/16/97) K103491/K052552 DePuy… | 2009 |
| * | K971883 | Synthes Spine Small Stature Anterior Cervical Vertebrae Plate SystemSummary page 2…1528 Pioneer Aspect Anterior Cervical Plate System (24-series, SE 8/24/11) K100708 Pioneer Anterior Cervical Plate System (SE 6/4/10) K083663 Pioneer PACP (SE 2/25/09) K971883 Synthes Spine Small Stature Anterior Cervical Plate System (SE 10/16/97) K103491/K052552 DePuy Spine, Inc. SKYLINE Anterior Cervi… | 1997 |
| * | K103491 | Skyline Anterior Cervical Plate SystemSummary page 2…8 Pioneer Anterior Cervical Plate System (SE 6/4/10) K083663 Pioneer PACP (SE 2/25/09) K971883 Synthes Spine Small Stature Anterior Cervical Plate System (SE 10/16/97) K103491/K052552 DePuy Spine, Inc. SKYLINE Anterior Cervical Plate System (SE 2/14/11) The subject Pioneer Aspect Anterior Cervical Plate… | 2011 |
| * | K052552 | Hybrid Anterior Cervical Plate SystemSummary page 2…r Anterior Cervical Plate System (SE 6/4/10) K083663 Pioneer PACP (SE 2/25/09) K971883 Synthes Spine Small Stature Anterior Cervical Plate System (SE 10/16/97) K103491/K052552 DePuy Spine, Inc. SKYLINE Anterior Cervical Plate System (SE 2/14/11) The subject Pioneer Aspect Anterior Cervical Plate System… | 2005 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 21 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 5 of the 33 ancestors have a recall of any class.
- Of its descendants, K183060 (Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.), 2019) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K111528.
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. 2013, 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 Pioneer Aspect Anterior Cervical Plate System is intended for anterior cervical fixation (C2-C7) for the following indications: 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, pseudoarthrosis, 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/K130427 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130427: Pioneer Aspect 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/K130427
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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