510(k) · Cleared
ClearedModification to Zplate-Atl Anterior Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Danek Medical, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jan 19, 1999 after a 158-day review. The FDA summary names no predicate by number. 2 later devices descend from it.
- Decided
- Jan 19, 1999
- Review
- 158 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK982875 Modification to Zplate-Atl Anterior Fixation SystemDanek Medical, Inc. · 1999
- Descendant · cites it directly · 1 of its ownK092765 Lanx Anterior Plating SystemLanx, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK202309 Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty…Zimmer Biomet Spine, Inc. · 2020
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 |
|---|---|---|---|---|---|
| 0 (this device) | K982875 | Modification to Zplate-Atl Anterior Fixation System | Danek Medical, Inc. | 1999 | — |
| +1 | K092765 | Lanx Anterior Plating System | Lanx, Inc. | 2010 | — |
| +2 | K202309 | Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation… | Zimmer Biomet Spine, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2020 | 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?
The FDA summary names no predicate by number.
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 |
|---|---|---|---|
| K092765 | Lanx Anterior Plating System | 2010 | 1 |
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?
- Of its descendants, K092765 (Lanx, Inc., 2010) has gone furthest, with 1 descendant of its own.
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 ZPLATE-ATL™ Anterior Fixation System is intended for screw/bolt fixation/ attachment to the anterolateral intervertebral bodies from T1 to LS only. This system is to be used only on one side and placed in such a manner as to be as far away from blood vessels such as the aorta and nerve roots as possible, When properly used, this system will provide temporary stabilization until 2 solid spinal fusion develops. Specific indications include: 1.…
Read the full statement (181 words)
The ZPLATE-ATL™ Anterior Fixation System is intended for screw/bolt fixation/ attachment to the anterolateral intervertebral bodies from T1 to LS only. This system is to be used only on one side and placed in such a manner as to be as far away from blood vessels such as the aorta and nerve roots as possible,
When properly used, this system will provide temporary stabilization until 2 solid spinal fusion develops. Specific indications include:
1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
2. Pseudoarthrosis.
3. Spondylolysis.
4. Spondylolisthesis.
5. Fracture.
6. Neoplastic disease.
7. Unsuccessful previous fusion surgery.
8. Lordotic deformities of the spine.
9. Idiopathic thoracolumbar or lumbar scoliosis
10. Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele.
11. Neuromuscular deformity (i.e., scoliosis, lordosis, and / or kyphosis) associated with pelvic obliquity.
Warning: This device is not approved for screw attachment to the posterior elements (pedicle) 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/K982875 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982875: Modification to Zplate-Atl Anterior Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982875
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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