510(k) · Cleared
ClearedCure™ OPEL-C Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meditech Spine, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Aug 31, 2018 as substantially equivalent to K160604 (Meditech Spine, LLC, 2016) after an 80-day review. Its family tree reaches back 3 generations to 1993. 1 later device descends from it.
- Decided
- Aug 31, 2018
- Review
- 80 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K926453 (1993). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK926453 Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa) · 1993
- 2 generations backK072650 Ist Anterior Cervical Plate SystemInnovative Spinal Technologies, Inc. · 2007
- 1 generation backK160604 Cure™ Anterior Cervical Plate (ACP) SystemMeditech Spine, LLC · 2016
- This deviceK181543 Cure™ OPEL-C Plate SystemMeditech Spine, LLC · 2018
- Descendant · cites it directly · 0 of its ownK200523 Biolign® Roto-Loc Cervical Plate SystemElite Surgical Supplies (Pty), Ltd. · 2020
Most influential descendants
Showing 1 of 1 · See all- K200523Biolign® Roto-Loc Cervical Plate SystemElite Surgical Supplies (Pty), Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K926453 | Synthes (U.S.a.) Anterior Cervical Vertebrae Plate | Synthes (Usa) | 1993 | — |
| −2 | K072650 | Ist Anterior Cervical Plate System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −1 | K160604 | Cure™ Anterior Cervical Plate (ACP) System | Meditech Spine, LLC | 2016 | — |
| 0 (this device) | K181543 | Cure™ OPEL-C Plate System | Meditech Spine, LLC | 2018 | — |
| +1 | K200523 | Biolign® Roto-Loc Cervical Plate System | Elite Surgical Supplies (Pty), Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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? (1)
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 |
|---|---|---|---|
| * | K160604 | Cure™ Anterior Cervical Plate (ACP) SystemSummary page 4…Spinal interverttebral body fixation ortho sis (21 CFR 888.3060 Class II,Product Code KWQ) C. Predicate Device: K160604 (Cure™ Anterior Cervical Plate System) D. Device Description: The Cure™ OPEL‐C (T) and Cure™ OPEL‐C (S) are available in a… | 2016 |
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 |
|---|---|---|---|
| K200523 | Biolign® Roto-Loc Cervical Plate System | 2020 | 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 25 years and passes through 3 companies; a new generation was cleared every 8.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K200523 (Elite Surgical Supplies (Pty), Ltd., 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K160604.
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 Cure™ OPEL-C System is intended for anterior screw fixation to the C2 to C7 levels of the cervical spine. The system is indicated for use in skeletally mature patients for temporary stabilization of the anterior spine during the development of cervical spine fusion in patients with Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), Spondylolisthesis, Trauma (i.e., fractures or dislocations), Deformity (defined as kyphosis, lordosis, or scoliosis), Pseudarthrosis, and Failed previous fusions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181543 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181543: Cure™ OPEL-C 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/K181543
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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