510(k) · Cleared
ClearedLOSPA IS ACP System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corentec Co., Ltd. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jan 5, 2017 as substantially equivalent to K063100 (Medtronic Sofamor Danek, Inc., 2007) and 1 other predicate after a 205-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- Jan 5, 2017
- Review
- 205 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K021461 (2002). 4 ancestors in all, the oldest K010115 (2001). No later device cites it as a predicate yet.
- Root · 2 generations backK021461 Atlantis Vision Anterior Cervical Plate SystemMedtronic Sofamor Danek · 2002 · Recalled
- 1 generation backK063100 Atlantis Anterior Cervical Plate System, Translational PlateMedtronic Sofamor Danek, Inc. · 2007 · Recalled
- This deviceK161641 LOSPA IS ACP SystemCorentec Co., Ltd. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K021461 | Atlantis Vision Anterior Cervical Plate System | Medtronic Sofamor Danek | 2002 | 3 |
| −1 | K063100 | Atlantis Anterior Cervical Plate System, Translational Plate | Medtronic Sofamor Danek, Inc. | 2007 | 3 |
| 0 (this device) | K161641 | LOSPA IS ACP System | Corentec Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K063100 | Atlantis Anterior Cervical Plate System, Translational PlateSummary page 6…ystems Category Medtronic Sofamor ATLANTIS Primary K063100 Danek USA ACP System ACP System Howmedica… | 2007 |
| * | K010115 | Reflex Anterior Cervical Plate SystemSummary page 6…System ACP System Howmedica Osteonics REFLEX ACP Additional K010115 Corp. (Stryker) System The LOSPA IS Spinal Systems consisting of Anterior Cervi… | 2001 |
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 15 years and passes through 3 companies; a new generation was cleared every 9.9 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 5 other devices also cite its predicate K063100.
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. 2017, 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?
LOSPA IS ACP System is intended for anterior intervertebral 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 following indication:
1) Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
2) Trauma (including fractures)
3) Tumors
4) Deformities or curvatures (including kyphosis, lordosis or scoliosis)
5) Pseudoarthrosis
6) Failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161641 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161641: LOSPA IS 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/K161641
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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