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 Sep 10, 2018 as substantially equivalent to K131200 (U&I Corporation, 2013) and 1 other predicate after a 41-day review. Its family tree reaches back 6 generations to 2000. 2 later devices descend from it.
- Decided
- Sep 10, 2018
- Review
- 41 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K002592 (2000). 36 ancestors in all, the oldest K792352 (1979). 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK002592 Interpore Cross Anterior Cervical Plate SystemInterpore Cross Intl. · 2000
- 5 generations backK040844 Life Spine Neo Anterior Cervical Plate SystemLife Spine, LLC · 2004
- 4 generations backK062831 Modification to Life Spine Neo Anterior Cervical Plate SystemLife Spine · 2006
- 3 generations backK093776 Indus Anterior Cervical Plate SystemSpinefrontier, Inc. · 2010
- 2 generations backK121060 Spine Frontier Indus Acp SystemSpinefrontier, Inc. · 2012 · Recalled
- 1 generation backK140234 Aspiron Acp SystemU&I Corp. · 2014
- This deviceK182055 SECULOK™ ACP SystemU&I Corporation · 2018
- Descendant · cites it directly · 1 of its ownK190053 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K002592 | Interpore Cross Anterior Cervical Plate System | Interpore Cross Intl. | 2000 | — |
| −5 | K040844 | Life Spine Neo Anterior Cervical Plate System | Life Spine, LLC | 2004 | — |
| −4 | K062831 | Modification to Life Spine Neo Anterior Cervical Plate System | Life Spine | 2006 | — |
| −3 | K093776 | Indus Anterior Cervical Plate System | Spinefrontier, Inc. | 2010 | — |
| −2 | K121060 | Spine Frontier Indus Acp System | Spinefrontier, Inc. | 2012 | 6 |
| −1 | K140234 | Aspiron Acp System | U&I Corp. | 2014 | — |
| 0 (this device) | K182055 | SECULOK™ ACP System | U&I Corporation | 2018 | — |
| +1 | 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 |
|---|---|---|
| 2019 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K131200 | Aspiron Acp SystemSummary page 4…al Intervertebral Body Fixation Orthosis Common Name: Anterior Cervical Plate Product Code: KWQ Predicate Devices: ASPIRON™ ACP System (K131200, K140234) Description of Device: The SECULOK™ ACP System consists of a variety of shapes and sizes of bone plates, screws and a… | 2013 |
| * | K140234 | Aspiron Acp SystemSummary page 4…ertebral Body Fixation Orthosis Common Name: Anterior Cervical Plate Product Code: KWQ Predicate Devices: ASPIRON™ ACP System (K131200, K140234) Description of Device: The SECULOK™ ACP System consists of a variety of shapes and sizes of bone plates, screws and associated… | 2014 |
What descends from it? (2)
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?
- The line of descent spans 18 years and passes through 6 companies; a new generation was cleared every 3.4 years on median.
- 3 of the 36 ancestors have a recall of any class.
- Of its descendants, K190053 (U&I Corporation, 2019) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K131200.
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. 2018, 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 as stated in the FDA summary.
https://510kreport.com/device/K182055 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182055: 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/K182055
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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