510(k) · Cleared
ClearedFrida™ Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spineup, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on May 23, 2025 as substantially equivalent to K160702 (Astura Medical, 2016) and 2 other predicates after a 98-day review. Its family tree reaches back 11 generations to 1999.
- Decided
- May 23, 2025
- Review
- 98 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K990745 (1999). 69 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet.
- Root · 11 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 7 generations between
- 3 generations backK200846 Balteum™ Lumbar Plate SystemHuvexel Co., Ltd. · 2020
- 2 generations backK213820 BALTEUM - ONE™ Lumbar Plate SystemHuvexel Co., Ltd. · 2022
- 1 generation backK222572 FORTIS and HANA Anterior Cervical Plate System, Rex Anterior…Dio Medical Corporation · 2022
- This deviceK250446 Frida™ Anterior Cervical Plate SystemSpineup, Inc. · 2025
Show all 11 generations
- Root · 11 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 10 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 9 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 8 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 7 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 6 generations backK062407 Gateway Thoracolumbar Plate SystemGlobus Medical, Inc. · 2006
- 5 generations backK092108 Truss Thoracolumbar Plate SystemGlobus Medical, Inc. · 2009
- 4 generations backK120092 Plymouth Thoracolumbar Plate SystemGlobus Medical, Inc. · 2012
- 3 generations backK200846 Balteum™ Lumbar Plate SystemHuvexel Co., Ltd. · 2020
- 2 generations backK213820 BALTEUM - ONE™ Lumbar Plate SystemHuvexel Co., Ltd. · 2022
- 1 generation backK222572 FORTIS and HANA Anterior Cervical Plate System, Rex Anterior…Dio Medical Corporation · 2022
- This deviceK250446 Frida™ Anterior Cervical Plate SystemSpineup, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −10 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −9 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −8 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −7 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −6 | K062407 | Gateway Thoracolumbar Plate System | Globus Medical, Inc. | 2006 | — |
| −5 | K092108 | Truss Thoracolumbar Plate System | Globus Medical, Inc. | 2009 | — |
| −4 | K120092 | Plymouth Thoracolumbar Plate System | Globus Medical, Inc. | 2012 | — |
| −3 | K200846 | Balteum™ Lumbar Plate System | Huvexel Co., Ltd. | 2020 | — |
| −2 | K213820 | BALTEUM - ONE™ Lumbar Plate System | Huvexel Co., Ltd. | 2022 | — |
| −1 | K222572 | FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate… | Dio Medical Corporation | 2022 | — |
| 0 (this device) | K250446 | Frida™ Anterior Cervical Plate System | Spineup, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 6 | 0 |
| 2004 | 7 | 0 |
| 2005 | 1 | 0 |
| 2006 | 5 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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? (3)
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 |
|---|---|---|---|
| * | K160702 | ZION Anterior Cervical Fixation SystemSummary page 5…888.3060 Product Code(s) KWQ | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K160702 ZION Anterior Cervical Fixation System KWQ K222572 Rex Anterior Cervical Plate System KWQ K080646 C-TEK MAXAN ANTERIOR CERVICAL P… | 2016 |
| * | K222572 | FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and…Summary page 5…redicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K160702 ZION Anterior Cervical Fixation System KWQ K222572 Rex Anterior Cervical Plate System KWQ K080646 C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM KWQ Device Description Summary 21 CFR 8… | 2022 |
| * | K080646 | C-Tek Maxan Anterior Cervical Plate SystemSummary page 5…# Predicate Trade Name (Primary Predicate is listed first) Product Code K160702 ZION Anterior Cervical Fixation System KWQ K222572 Rex Anterior Cervical Plate System KWQ K080646 C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM KWQ Device Description Summary 21 CFR 807.92(a)(4) The Frida™ Anterior Cervical Plate… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 5 of the 69 ancestors have a recall of any class.
- 2 other devices also cite its predicate K160702.
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. 2025, 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 Frida™ Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine in skeletally mature patients, serving as an adjunct to fusion of the cervical spine (C2 - T1). The system is intended for the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications: 1) degenerative disc disease (as defined as neck pain of discogenic origin and confirmed by patient history and radiographic studies), 2) spondylolisthesis, 3) spinal stenosis, 4) trauma, 5) failed previous fusions, 6) tumors, 7) curvature deformities (kyphosis, lordosis, or scoliosis), and/or 8) pseudoarthrosis.
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/K250446 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250446: Frida™ 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/K250446
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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