510(k) · Cleared
ClearedAsfora Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Designs, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jul 1, 2015 as substantially equivalent to K122497 (Medical Design, LLC, 2012) and 1 other predicate after a 189-day review. Its family tree reaches back 4 generations to 1993.
- Decided
- Jul 1, 2015
- Review
- 189 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K926453 (1993). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK926453 Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa) · 1993
- 3 generations backK971883 Synthes Spine Small Stature Anterior Cervical Vertebrae Plate SystemSynthes (Usa) · 1997 · Recalled
- 2 generations backK022344 Trinica Select Anterior Cervical Plate SystemCenterpulse Spine-Tech, Inc. · 2002 · Recalled
- 1 generation backK122497 Asfora Anterior Cervical Plate System, One Level, 14MM Asfora…Medical Design, LLC · 2012
- This deviceK143688 Asfora Anterior Cervical Plate SystemMedical Designs, LLC · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K926453 | Synthes (U.S.a.) Anterior Cervical Vertebrae Plate | Synthes (Usa) | 1993 | — |
| −3 | K971883 | Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System | Synthes (Usa) | 1997 | 1 |
| −2 | K022344 | Trinica Select Anterior Cervical Plate System | Centerpulse Spine-Tech, Inc. | 2002 | 1 |
| −1 | K122497 | Asfora Anterior Cervical Plate System, One Level, 14MM Asfora Anterior… | Medical Design, LLC | 2012 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K122497 | Asfora Anterior Cervical Plate System, One Level, 14MM Asfora Anterior Cervical Plate…Summary page 4…WQ Device Class: Class II Classification Panel: Orthopaedic and Rehabilitation Devices Panel 5. Predicate Devices Primary: K122497 Asfora Anterior Cervical Plate System Additional: K030866 Synthes Cervical Spine Locking Plate 6. Device… | 2012 |
| * | K030866 | Synthes Anterior CSLP SystemSummary page 4…l: Orthopaedic and Rehabilitation Devices Panel 5. Predicate Devices Primary: K122497 Asfora Anterior Cervical Plate System Additional: K030866 Synthes Cervical Spine Locking Plate 6. Device Description The Asfora Anterior Cervical Plate System is composed of… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- 2 of the 9 ancestors have a recall of any class.
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. 2015, 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 spine fusions (C2-T1) 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/K143688 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143688: Asfora 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/K143688
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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