510(k) · Cleared
ClearedAsfora Anterior Cervical Plate System, One Level, 14MM Asfora Anterior Cervical Plate System, One Level, 16MM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Design, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Oct 15, 2012 as substantially equivalent to K030866 (Synthes (Usa), 2003) and 1 other predicate after a 60-day review. Its family tree reaches back 3 generations to 1993. 1 later device descends from it.
- Decided
- Oct 15, 2012
- Review
- 60 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K926453 (1993). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK926453 Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa) · 1993
- 2 generations backK971883 Synthes Spine Small Stature Anterior Cervical Vertebrae Plate SystemSynthes (Usa) · 1997 · Recalled
- 1 generation backK022344 Trinica Select Anterior Cervical Plate SystemCenterpulse Spine-Tech, Inc. · 2002 · Recalled
- This deviceK122497 Asfora Anterior Cervical Plate System, One Level, 14MM Asfora…Medical Design, LLC · 2012
- Descendant · cites it directly · 0 of its ownK143688 Asfora Anterior Cervical Plate SystemMedical Designs, LLC · 2015
Most influential descendants
Showing 1 of 1 · See all- K143688Asfora Anterior Cervical Plate SystemMedical Designs, LLC · 2015 · cites it directly0descendants
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 | K971883 | Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System | Synthes (Usa) | 1997 | 1 |
| −1 | K022344 | Trinica Select Anterior Cervical Plate System | Centerpulse Spine-Tech, Inc. | 2002 | 1 |
| 0 (this device) | K122497 | Asfora Anterior Cervical Plate System, One Level, 14MM Asfora Anterior… | Medical Design, LLC | 2012 | — |
| +1 | K143688 | Asfora Anterior Cervical Plate System | Medical Designs, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | K030866 | Synthes Anterior CSLP SystemSummary page 1…Code: KWQ Predicate The subject device is substantially equivalent to the following devices: Device(s): * Synthes Anterior CSLP System (Synthes, K030866) * Trinica SeleCtTM Anterior Cervical Plate System (Centerpulse Spine-Tech, K022344… | 2003 |
| * | K022344 | Trinica Select Anterior Cervical Plate SystemSummary page 1…Synthes Anterior CSLP System (Synthes, K030866) * Trinica SeleCtTM Anterior Cervical Plate System (Centerpulse Spine-Tech, K022344), currently marketed by Zimmer Spine Device The Asfora Anterior Cervical Plate System is composed of plates of Descri… | 2002 |
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 |
|---|---|---|---|
| K143688 | Asfora Anterior Cervical Plate System | 2015 | 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 19 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K143688 (Medical Designs, LLC, 2015) has gone furthest, with 0 descendants of its own.
- 41 other devices also cite its predicate K030866.
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. 2012, 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 Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical fusions (C2-TL) 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 as stated in the FDA summary.
https://510kreport.com/device/K122497 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122497: Asfora Anterior Cervical Plate System, One Level, 14MM Asfora Anterior Cervical Plate System, One Level, 16MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122497
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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