510(k) · Cleared
ClearedLnK Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
L&K BIOMED Co., Ltd. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Mar 20, 2015 as substantially equivalent to K113509 (L&K BIOMED Co., Ltd., 2012) after a 126-day review. Its family tree reaches back 3 generations to 2000. 5 later devices descend from it.
- Decided
- Mar 20, 2015
- Review
- 126 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K994239 (2000). 5 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK994239 Zephir Anterior Cervical Plate SystemMedtronic Sofamor Danek, Inc. · 2000
- 2 generations backK061002 Maxima Anterior Cervical Plate SystemU&I Corp. · 2006
- 1 generation backK113509 Lexus Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2012
- This deviceK143279 LnK Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2015
- Descendant · cites it directly · 2 of its ownK231839 CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate…L&K BIOMED Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK261112 CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK251940 PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK183073 SMG Anterior Cervical Plate SystemSapphire Medical Group · 2019
- Descendant · cites it directly · 0 of its ownK181190 Pinehurst Anterior Cervical Plate SystemSignature Orthopaedics Pty, Ltd. · 2019
Most influential descendants
Showing 5 of 5 · See all- K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2023 · cites it directly2descendants
- K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2026 · 2 generations on0descendants
- K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2026 · 2 generations on0descendants
- K183073SMG Anterior Cervical Plate SystemSapphire Medical Group · 2019 · cites it directly0descendants
- K181190Pinehurst Anterior Cervical Plate SystemSignature Orthopaedics Pty, Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K994239 | Zephir Anterior Cervical Plate System | Medtronic Sofamor Danek, Inc. | 2000 | — |
| −2 | K061002 | Maxima Anterior Cervical Plate System | U&I Corp. | 2006 | — |
| −1 | K113509 | Lexus Anterior Cervical Plate System | L&K BIOMED Co., Ltd. | 2012 | — |
| 0 (this device) | K143279 | LnK Anterior Cervical Plate System | L&K BIOMED Co., Ltd. | 2015 | — |
| +1 | K231839 | CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System | L&K BIOMED Co., Ltd. | 2023 | — |
| +2 | K261112 | CastleLoc-P Anterior Cervical Plate System | L&K BIOMED Co., Ltd. | 2026 | — |
| +2 | K251940 | PathLoc Lumbar Plate System | L&K BIOMED Co., Ltd. | 2026 | — |
| +1 | K183073 | SMG Anterior Cervical Plate System | Sapphire Medical Group | 2019 | — |
| +1 | K181190 | Pinehurst Anterior Cervical Plate System | Signature Orthopaedics Pty, Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K113509 | Lexus Anterior Cervical Plate SystemSummary page 4…(21 CFR 888.3060) 3. Predicate or legally marketed devices which are substantially equivalent L&K Biomed: LnK Anterior Cervical Plate System (K113509) (Primary) 4. Description of the Device The LnK Anterior Cervical Plate System is composed of plates and screws whic… | 2012 |
What descends from it? (5)
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 15 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K231839 (L&K BIOMED Co., Ltd., 2023) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K113509.
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. 2015, 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 LnK Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization and stabilization of the spine as an adjunct to fusions 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),
• tumors,
• deformity (defined as kyphosis, lordosis, or scoliosis),
• pseudoarthrosis,
• failed previous fusion,
• spinal stenosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143279 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143279: LnK 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/K143279
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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