510(k) · Cleared
ClearedSECULOK™ ACP System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
U&I Corporation · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Feb 1, 2019 as substantially equivalent to K182055 (U&I Corporation, 2018) and 2 other predicates after a 21-day review. Its family tree reaches back 7 generations to 2000. 1 later device descends from it.
- Decided
- Feb 1, 2019
- Review
- 21 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K002592 (2000). 37 ancestors in all, the oldest K792352 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK002592 Interpore Cross Anterior Cervical Plate SystemInterpore Cross Intl. · 2000
- 6 generations backK040844 Life Spine Neo Anterior Cervical Plate SystemLife Spine, LLC · 2004
- 5 generations backK062831 Modification to Life Spine Neo Anterior Cervical Plate SystemLife Spine · 2006
- 4 generations backK093776 Indus Anterior Cervical Plate SystemSpinefrontier, Inc. · 2010
- 3 generations backK121060 Spine Frontier Indus Acp SystemSpinefrontier, Inc. · 2012 · Recalled
- 2 generations backK140234 Aspiron Acp SystemU&I Corp. · 2014
- 1 generation backK182055 SECULOK™ ACP SystemU&I Corporation · 2018
- This deviceK190053 SECULOK™ ACP SystemU&I Corporation · 2019
- Descendant · cites it directly · 0 of its ownK220147 Aspiron S ACP SystemU&I Corporation · 2022
Most influential descendants
Showing 1 of 1 · See all- K220147Aspiron S ACP SystemU&I Corporation · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K002592 | Interpore Cross Anterior Cervical Plate System | Interpore Cross Intl. | 2000 | — |
| −6 | K040844 | Life Spine Neo Anterior Cervical Plate System | Life Spine, LLC | 2004 | — |
| −5 | K062831 | Modification to Life Spine Neo Anterior Cervical Plate System | Life Spine | 2006 | — |
| −4 | K093776 | Indus Anterior Cervical Plate System | Spinefrontier, Inc. | 2010 | — |
| −3 | K121060 | Spine Frontier Indus Acp System | Spinefrontier, Inc. | 2012 | 6 |
| −2 | K140234 | Aspiron Acp System | U&I Corp. | 2014 | — |
| −1 | K182055 | SECULOK™ ACP System | U&I Corporation | 2018 | — |
| 0 (this device) | K190053 | SECULOK™ ACP System | U&I Corporation | 2019 | — |
| +1 | K220147 | Aspiron S ACP System | U&I Corporation | 2022 | — |
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 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K182055 | SECULOK™ ACP SystemSummary page 4…tervertebral Body Fixation Orthosis Common Name: Anterior Cervical Plate Product Code: KWQ Predicate Devices: Primary - SECULOK™ ACP System (K182055) Secondary - ASPIRON™ ACP System (K131200, K140234) Description of Device: The SECULOKŒ ACP System consists of a variety of s… | 2018 |
| * | K131200 | Aspiron Acp SystemSummary page 4…Name: Anterior Cervical Plate Product Code: KWQ Predicate Devices: Primary - SECULOK™ ACP System (K182055) Secondary - ASPIRON™ ACP System (K131200, K140234) Description of Device: The SECULOKŒ ACP System consists of a variety of shapes and sizes of bone plates, screws and a… | 2013 |
| * | K140234 | Aspiron Acp SystemSummary page 4…Anterior Cervical Plate Product Code: KWQ Predicate Devices: Primary - SECULOK™ ACP System (K182055) Secondary - ASPIRON™ ACP System (K131200, K140234) Description of Device: The SECULOKŒ ACP System consists of a variety of shapes and sizes of bone plates, screws and associated… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220147 | Aspiron S ACP System | 2022 | 0 |
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 19 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 37 ancestors have a recall of any class.
- Of its descendants, K220147 (U&I Corporation, 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K182055.
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. 2019, 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 SECULOK™ ACP System is intended for anterior vertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications: Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration disc confirmed by patient history and radiographic studies); Spondylolisthesis Trauma…
Read the full statement (105 words)
The SECULOK™ ACP System is intended for anterior vertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration disc confirmed by patient history and radiographic studies);
Spondylolisthesis
Trauma (including fractures, dislocation)
Spinal stenosis
Tumors
Deformity (defined as scoliosis, kyphosis, or lordosis
Pseudoarthrosis
Failed previous fusion
WARNING: The device is not approved for screw attachment or fixation to the posterior elements (pedicles) 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/K190053 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190053: SECULOK™ ACP System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190053
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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