510(k) · Cleared
ClearedLDR Spine Usa C-Plate, TL Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ldr Spine USA · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Sep 29, 2010 as substantially equivalent to K061002 (U&I Corp., 2006) after a 50-day review. Its family tree reaches back 2 generations to 2000. 7 later devices descend from it.
- Decided
- Sep 29, 2010
- Review
- 50 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K994239 (2000). 3 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK994239 Zephir Anterior Cervical Plate SystemMedtronic Sofamor Danek, Inc. · 2000
- 1 generation backK061002 Maxima Anterior Cervical Plate SystemU&I Corp. · 2006
- This deviceK102265 LDR Spine Usa C-Plate, TL Anterior Cervical Plate SystemLdr Spine USA · 2010
- Descendant · cites it directly · 6 of its ownK153526 Pyrenees Cervical Plate SystemK2m · 2016
- Descendant · 2 generations on · 5 of its ownK162664 Pyrenees Cervical Plate SystemK2m, Inc. · 2016
- Descendant · 3 generations on · 4 of its ownK182473 PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System…K2m, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK242361 OZARK Cervical Plate System; PYRENEES® Cervical Plate System…Stryker Spine · 2024
- Descendant · 4 generations on · 1 of its ownK221728 Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System…Stryker Corporation · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K153526Pyrenees Cervical Plate SystemK2m · 2016 · cites it directly6descendants
- K162664Pyrenees Cervical Plate SystemK2m, Inc. · 2016 · 2 generations on5descendants
- K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc. · 2018 · 3 generations on4descendants
- K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine · 2024 · 2 generations on1descendant
- K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation · 2022 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K994239 | Zephir Anterior Cervical Plate System | Medtronic Sofamor Danek, Inc. | 2000 | — |
| −1 | K061002 | Maxima Anterior Cervical Plate System | U&I Corp. | 2006 | — |
| 0 (this device) | K102265 | LDR Spine Usa C-Plate, TL Anterior Cervical Plate System | Ldr Spine USA | 2010 | — |
| +1 | K153526 | Pyrenees Cervical Plate System | K2m | 2016 | — |
| +2 | K162664 | Pyrenees Cervical Plate System | K2m, Inc. | 2016 | — |
| +3 | K182473 | PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK… | K2m, Inc. | 2018 | — |
| +2 | K242361 | OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal… | Stryker Spine | 2024 | — |
| +4 | K221728 | Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™… | Stryker Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K061002 | Maxima Anterior Cervical Plate SystemSummary page 1…60) - Spinal intervertebral body fixation orthosis 5. Legally Marketed Equivalent Predicate Device: MAXIMA Tm Anterior Cervical Plate System (K061002) 6. Device Description The C-Plate Anterior Cervical Plate System consists of a variety of shapes and sizes of Main Plates… | 2006 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153526 | Pyrenees Cervical Plate System | 2016 | 6 |
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?
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. 2010, 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 C-Plate Tm Anterior Cervical Plate System is intended for anterior cervical fixation for the following indications:
* Degenerative disc disease (DOD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
* Spondylolisthesis
* Trauma (i.e., fracture or dislocation)
* Spinal stenosis
* Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
* Tumor
* Pseudloarthrosis
* Failed previous fusion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102265 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102265: LDR Spine Usa C-Plate, TL Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102265
Report an extraction error
Are you the manufacturer?
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