510(k) · Cleared
ClearedAnterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scien'Tx USA, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jan 14, 2002 as substantially equivalent to K973854 (Sofamor Danek USA,Inc., 1998) and 1 other predicate after an 89-day review. Its family tree reaches back 1 generation to 1997. 64 later devices descend from it.
- Decided
- Jan 14, 2002
- Review
- 89 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K971730 (1997). 2 ancestors in all. 64 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK971730 Depuy Motech Peak Polyaxial Anterior Cervical Plate SystemDepuy, Inc. · 1997
- This deviceK013439 Anterior Cervical Plate SystemScien'Tx USA, Inc. · 2002
- Descendant · cites it directly · 63 of its ownK042317 Cervical PlateScient'X · 2004
- Descendant · 2 generations on · 62 of its ownK070681 Next Generation Anterior Cervical Plating SystemAlphatec Spine, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 38 of its ownK102820 Appliance, Fixation, Spinal Intervertebral BodyAlphatec Spine, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 26 of its ownK112533 Zavation Cervical Plate SystemZavation, LLC · 2011
- Descendant · 4 generations on · 18 of its ownK163104 Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017
Showing 5 of 64 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 64 · See all- K042317Cervical PlateScient'X · 2004 · cites it directly63descendants
- K070681Next Generation Anterior Cervical Plating SystemAlphatec Spine, Inc. · 2007 · 2 generations on62descendants
- K102820Appliance, Fixation, Spinal Intervertebral BodyAlphatec Spine, Inc. · 2010 · 3 generations on38descendants
- K112533Zavation Cervical Plate SystemZavation, LLC · 2011 · 3 generations on26descendants
- K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017 · 4 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971730 | Depuy Motech Peak Polyaxial Anterior Cervical Plate System | Depuy, Inc. | 1997 | — |
| 0 (this device) | K013439 | Anterior Cervical Plate System | Scien'Tx USA, Inc. | 2002 | — |
| +1 | K042317 | Cervical Plate | Scient'X | 2004 | — |
| +2 | K070681 | Next Generation Anterior Cervical Plating System | Alphatec Spine, Inc. | 2007 | 1 |
| +3 | K102820 | Appliance, Fixation, Spinal Intervertebral Body | Alphatec Spine, Inc. | 2010 | 2 |
| +3 | K112533 | Zavation Cervical Plate System | Zavation, LLC | 2011 | — |
| +4 | K163104 | Terrace™ Anterior Cervical Plate System | Corelink, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 5 | 0 |
| 2019 | 2 | 0 |
| 2020 | 6 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 8 | 0 |
| 2024 | 9 | 0 |
| 2025 | 10 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K973854 | Orion Anterior Cervical Plate SystemSummary page 1…@) Basis for substantial equivalence: The Anterior Cervical Plate System has similar design characteristics, i.e., material, screw size, and indications, a8 the Orion (K973854) and PEAK System (K971730) systems distributed by Sofamor Danek and DePuy Motech, respectively. & C DEPARTMENT OF… | 1998 |
| * | K971730 | Depuy Motech Peak Polyaxial Anterior Cervical Plate SystemSummary page 1…equivalence: The Anterior Cervical Plate System has similar design characteristics, i.e., material, screw size, and indications, a8 the Orion (K973854) and PEAK System (K971730) systems distributed by Sofamor Danek and DePuy Motech, respectively. & C DEPARTMENT OF HEALTH & HUMAN SERVICES P… | 1997 |
What descends from it? (64)
See all 641 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042317 | Cervical Plate | 2004 | 63 |
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?
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.
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 Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of a solid spinal fusion in patients with neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies (DDD), trauma (i.e. fractures), tumors, deformities (i.e. kyphosis, lordosis, and scoliosis), pseudoarthrosis, spinal stenosis, and failed previous fusions.
WARNING: These devices are not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
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/K013439 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013439: Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013439
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026