510(k) · Cleared
ClearedAspiron 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 Aug 29, 2013 as substantially equivalent to K061002 (U&I Corp., 2006) and 2 other predicates after a 122-day review. Its family tree reaches back 4 generations to 1992. 7 later devices descend from it.
- Decided
- Aug 29, 2013
- Review
- 122 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K922087 (1992). 16 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 3 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
- 2 generations backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
- 1 generation backK012184 Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2002
- This deviceK131200 Aspiron Acp SystemU&I Corporation · 2013
- Descendant · cites it directly · 6 of its ownK140234 Aspiron Acp SystemU&I Corp. · 2014
- Descendant · 2 generations on · 2 of its ownK231251 FlexWing Anterior Cervical Plate SystemJeil Medical Corporation · 2024
- Descendant · cites it directly · 2 of its ownK182055 SECULOK™ ACP SystemU&I Corporation · 2018
- Descendant · cites it directly · 1 of its ownK190053 SECULOK™ ACP SystemU&I Corporation · 2019
- Descendant · 3 generations on · 0 of its ownK252826 ARIX Femur Nail SystemJeil Medical Corporation · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K140234Aspiron Acp SystemU&I Corp. · 2014 · cites it directly6descendants
- K231251FlexWing Anterior Cervical Plate SystemJeil Medical Corporation · 2024 · 2 generations on2descendants
- K182055SECULOK™ ACP SystemU&I Corporation · 2018 · cites it directly2descendants
- K190053SECULOK™ ACP SystemU&I Corporation · 2019 · cites it directly1descendant
- K252826ARIX Femur Nail SystemJeil Medical Corporation · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K922087 | Anterior Cervical Plate System | Sofamor Danek Mfg., Inc. | 1992 | — |
| −3 | K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System | Spinal Concepts, Inc. | 1999 | 1 |
| −2 | K000486 | Abc Cervical Plating System | Aesculap, Inc. | 2000 | — |
| −1 | K012184 | Blackstone Iii Anterior Cervical Plating System | Blackstone Medical, Inc. | 2002 | — |
| 0 (this device) | K131200 | Aspiron Acp System | U&I Corporation | 2013 | — |
| +1 | K140234 | Aspiron Acp System | U&I Corp. | 2014 | — |
| +2 | K231251 | FlexWing Anterior Cervical Plate System | Jeil Medical Corporation | 2024 | — |
| +1 | K182055 | SECULOK™ ACP System | U&I Corporation | 2018 | — |
| +1 | K190053 | SECULOK™ ACP System | U&I Corporation | 2019 | — |
| +3 | K252826 | ARIX Femur Nail System | Jeil Medical Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 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? (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 |
|---|---|---|---|
| * | K061002 | Maxima Anterior Cervical Plate SystemSummary page 1…888.3060 Common Name: Anterior Cervical Plate Product Code: KWQ Predicate Devices: Maxima Tm Anterior Cervical Plate System (K061002) Blackstone TM 1110 Anterior Cervical Plating System… | 2006 |
| * | K012184 | Blackstone Iii Anterior Cervical Plating SystemSummary page 1…l Plate System (K061002) Blackstone TM 1110 Anterior Cervical Plating System (K012184~ ZEPHIR t Anterior Cervical Plate System (K994239) Description of Device: ASPIRON TM ACP System co… | 2002 |
| * | K994239 | Zephir Anterior Cervical Plate SystemSummary page 1…Anterior Cervical Plating System (K012184~ ZEPHIR t Anterior Cervical Plate System (K994239) Description of Device: ASPIRON TM ACP System consists of a variety of shapes and size of bone plates, screws and associa… | 2000 |
What descends from it? (7)
3 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 21 years and passes through 5 companies; a new generation was cleared every 6.3 years on median.
- 2 of the 16 ancestors have a recall of any class.
- Of its descendants, K140234 (U&I Corp., 2014) has gone furthest, with 6 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. 2013, 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 ASPIRON TM ACP System is intended for anterior inter-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); *…
Read the full statement (113 words)
The ASPIRON TM ACP System is intended for anterior inter-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, orilordosis)
* Pseudloarthrosis
* 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/K131200 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131200: Aspiron Acp System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131200
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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