510(k) · Cleared
ClearedRex Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dio Medical Co., Ltd. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Oct 31, 2012 as substantially equivalent to K061002 (U&I Corp., 2006) and 1 other predicate after a 127-day review. Its family tree reaches back 4 generations to 1998. 7 later devices descend from it.
- Decided
- Oct 31, 2012
- Review
- 127 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K973854 (1998). 10 ancestors in all, the oldest K792352 (1979). 7 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK973854 Orion Anterior Cervical Plate SystemSofamor Danek USA,Inc. · 1998
- 3 generations backK042235 Orion Anterior Cervical Plating SystemMedtronic Sofamor Danek · 2004
- 2 generations backK042922 Venture Anterior Cervical Plating SystemMedtronic Sofamor Danek, Inc. · 2004
- 1 generation backK061274 Venture Anterior Cervical Plate SystemMedtronic Sofamor Danek · 2006
- This deviceK121862 Rex Anterior Cervical Plate SystemDio Medical Co., Ltd. · 2012
- Descendant · cites it directly · 4 of its ownK173099 Fortis and Hana Anterior Cervical Plate SystemHuvexel Co., Ltd. · 2017
- Descendant · cites it directly · 2 of its ownK222572 FORTIS and HANA Anterior Cervical Plate System, Rex Anterior…Dio Medical Corporation · 2022
- Descendant · 2 generations on · 0 of its ownK250446 Frida™ Anterior Cervical Plate SystemSpineup, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK231460 FORTIS and HANA Anterior Cervical Plate System, Rex Anterior…K&J Consulting Corp. · 2023
- Descendant · 2 generations on · 0 of its ownK220379 IMPEACE and IMPEACE-Uni Anterior Cervical Plate SystemMedynus, Inc. · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K173099Fortis and Hana Anterior Cervical Plate SystemHuvexel Co., Ltd. · 2017 · cites it directly4descendants
- K222572FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and…Dio Medical Corporation · 2022 · cites it directly2descendants
- K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc. · 2025 · 2 generations on0descendants
- K231460FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System…K&J Consulting Corp. · 2023 · 2 generations on0descendants
- K220379IMPEACE and IMPEACE-Uni Anterior Cervical Plate SystemMedynus, Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K973854 | Orion Anterior Cervical Plate System | Sofamor Danek USA,Inc. | 1998 | — |
| −3 | K042235 | Orion Anterior Cervical Plating System | Medtronic Sofamor Danek | 2004 | — |
| −2 | K042922 | Venture Anterior Cervical Plating System | Medtronic Sofamor Danek, Inc. | 2004 | — |
| −1 | K061274 | Venture Anterior Cervical Plate System | Medtronic Sofamor Danek | 2006 | — |
| 0 (this device) | K121862 | Rex Anterior Cervical Plate System | Dio Medical Co., Ltd. | 2012 | — |
| +1 | K173099 | Fortis and Hana Anterior Cervical Plate System | Huvexel Co., Ltd. | 2017 | — |
| +1 | K222572 | FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate… | Dio Medical Corporation | 2022 | — |
| +2 | K250446 | Frida™ Anterior Cervical Plate System | Spineup, Inc. | 2025 | — |
| +2 | K231460 | FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate… | K&J Consulting Corp. | 2023 | — |
| +2 | K220379 | IMPEACE and IMPEACE-Uni Anterior Cervical Plate System | Medynus, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2017 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K061002 | Maxima Anterior Cervical Plate SystemSummary page 2…n. Predicate Devices: The subject device is substantially equivalent to the following predicate devices: *U&l corporation. Maxima TM Anterior Cervical Plate System (K06 1002) *Medtronic Sofamor Danek. VENTURE TM Anterior Cervical Plate System (K06 1274) Comparison to Predicate Devices: T… | 2006 |
| * | K061274 | Venture Anterior Cervical Plate SystemSummary page 2…llowing predicate devices: *U&l corporation. Maxima TM Anterior Cervical Plate System (K06 1002) *Medtronic Sofamor Danek. VENTURE TM Anterior Cervical Plate System (K06 1274) Comparison to Predicate Devices: The Substantial equivalence of this device is based on equivalence in intended use,… | 2006 |
What descends from it? (7)
4 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?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 6.4 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K173099 (Huvexel Co., Ltd., 2017) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K061002.
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. 2012, 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 REX Anterior Cervical Plate System is intended for anterior fixation to the cervical spine. The specific clinical indications include:
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/K121862 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121862: Rex 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/K121862
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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