510(k) · Cleared
ClearedPremier Anterior Cervical Plate 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 Sep 17, 2002 after a 111-day review. The FDA summary names its predicate without a number. 10 later devices descend from it.
- Decided
- Sep 17, 2002
- Review
- 111 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK021761 Premier Anterior Cervical Plate SystemMedtronic Sofamor Danek · 2002
- Descendant · cites it directly · 8 of its ownK182885 Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical…Medtronic Sofamor Danek USA, Inc. · 2019
- Descendant · 2 generations on · 4 of its ownK192502 Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical…Medtronic Sofamor Danek USA, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK191584 FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC · 2019
- Descendant · 3 generations on · 1 of its ownK241164 IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic) · 2024 · Recalled
- Descendant · 4 generations on · 0 of its ownK253577 IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic) · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc. · 2019 · cites it directly8descendants
- K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc. · 2020 · 2 generations on4descendants
- K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC · 2019 · 2 generations on2descendants
- K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic) · 2024 · 3 generations on1descendant
- K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic) · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021761 | Premier Anterior Cervical Plate System | Medtronic Sofamor Danek | 2002 | — |
| +1 | K182885 | Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion… | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| +2 | K192502 | Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion… | Medtronic Sofamor Danek USA, Inc. | 2020 | — |
| +2 | K191584 | FORTICO Anterior Cervical Fixation System | Camber Spine Technologies, LLC | 2019 | — |
| +3 | K241164 | IB3D™ PL Spinal System | Medicrea International S.A.S. (Medtronic) | 2024 | 2 |
| +4 | K253577 | IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) | Medicrea International S.A.S. (Medtronic) | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | — | PREMIER Anterior Cervical Plate System Named without a submission number |
What descends from it? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K182885 (Medtronic Sofamor Danek USA, Inc., 2019) has gone furthest, with 8 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 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 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/K021761 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021761: Premier Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021761
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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