510(k) · Cleared
ClearedZephir Anterior Cervical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Feb 26, 2003 after a 26-day review. The FDA summary names no predicate by number. 1 of the 369 devices in its family, counting itself, has a Class I recall. 368 later devices descend from it.
- Decided
- Feb 26, 2003
- Review
- 26 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
368 later devices descend from it, 13 citing it directly. 1 of the 369 devices in this family, counting this one, has a Class I recall.
- This deviceK030327 Zephir Anterior Cervical SystemMedtronic Sofamor Danek · 2003
- Descendant · cites it directly · 281 of its ownK122037 Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion…Medtronic Sofamor Danek, Inc. · 2013
- Descendant · 2 generations on · 228 of its ownK150135 DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2015
- Descendant · 3 generations on · 190 of its ownK152277 PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
- Descendant · 4 generations on · 155 of its ownK161379 ELSA SpacersGlobus Medical, Inc. · 2016
- Descendant · 2 generations on · 130 of its ownK142559 ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
Showing 5 of 368 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 368 · See all- K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc. · 2013 · cites it directly281descendants
- K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2015 · 2 generations on228descendants
- K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015 · 3 generations on190descendants
- K161379ELSA SpacersGlobus Medical, Inc. · 2016 · 4 generations on155descendants
- K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015 · 2 generations on130descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030327 | Zephir Anterior Cervical System | Medtronic Sofamor Danek | 2003 | — |
| +1 | K122037 | Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System… | Medtronic Sofamor Danek, Inc. | 2013 | — |
| +2 | K150135 | DIVERGENCE-L Anterior/Oblique Lumbar Fusion System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| +3 | K152277 | PIVOX (tm) Oblique Lateral Spinal System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| +4 | K161379 | ELSA Spacers | Globus Medical, Inc. | 2016 | — |
| +2 | K142559 | ELEVATE Spinal System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 6 | 0 |
| 2014 | 10 | 0 |
| 2015 | 11 | 0 |
| 2016 | 7 | 0 |
| 2017 | 15 | 0 |
| 2018 | 8 | 0 |
| 2019 | 24 | 0 |
| 2020 | 16 | 0 |
| 2021 | 30 | 1 |
| 2022 | 35 | 0 |
| 2023 | 41 | 0 |
| 2024 | 55 | 0 |
| 2025 | 50 | 0 |
| 2026 | 49 | 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.
1 device in this family has a Class I recall. 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? (368)
See all 36813 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122037 | Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail… | 2013 | 281 |
| K063100 | Atlantis Anterior Cervical Plate System, Translational Plate | 2007 | 50 |
| K061002 | Maxima Anterior Cervical Plate System | 2006 | 44 |
| K113509 | Lexus Anterior Cervical Plate System | 2012 | 19 |
| K141632 | Zevo (TM) Anterior Cervical Plate System | 2014 | 18 |
| K141599 | Divergence Anterior Cervical Fusion System | 2015 | 16 |
| K140417 | Divergence Mini-Plate Anterior Cervical Fusion System | 2014 | 11 |
| K182885 | Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™… | 2019 | 8 |
| K092474 | Pyrenees Cervical Plate System, Semi-Constrained Screws | 2010 | 8 |
| K112809 | Blue Mountain Cervical Plate | 2012 | 2 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K122037 (Medtronic Sofamor Danek, Inc., 2013) has gone furthest, with 281 descendants 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?
Properly used, this system is intended for anterior interbody screw/plate fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with…
Read the full statement (134 words)
Properly used, this system is intended for anterior interbody screw/plate fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions.
Nota Bene: This device system is intended for anterior cervical intervertebral body fusions only.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030327 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030327: Zephir Anterior Cervical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030327
Report an extraction error
Are you the manufacturer?
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