510(k) · Cleared
ClearedLnK Posterior Cervical Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
L&K BIOMED Co., Ltd. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Jul 29, 2015 as substantially equivalent to K120879 (L&K BIOMED Co., Ltd., 2012) after a 257-day review. Its family tree reaches back 12 generations to 1985. 13 later devices descend from it.
- Decided
- Jul 29, 2015
- Review
- 257 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K853033 (1985). 23 ancestors in all. 13 later devices descend from it, 3 citing it directly.
- Root · 12 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 8 generations between
- 3 generations backK060152 Modification to S4 Spinal SystemAesculap, Inc. · 2006
- 2 generations backK103414 Venus Cervical Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2011
- 1 generation backK120879 Lexus Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2012
- This deviceK143278 LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2015
- Descendant · cites it directly · 12 of its ownK162136 CastleLoc-S Posterior Cervical Fixation System; LnK Posterior…L&K BIOMED Co., Ltd. · 2016
- Descendant · cites it directly · 11 of its ownK200793 LnK Posterior Cervical Fixation System and CastleLoc-S Posterior…L&K BIOMED Co., Ltd. · 2020
- Descendant · 2 generations on · 10 of its ownK210035 ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical…Aegis Spine · 2021
- Descendant · 2 generations on · 6 of its ownK221050 ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation…Aegis Spine, Inc. · 2022
- Descendant · 3 generations on · 3 of its ownK223719 Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc. · 2023
Show all 12 generations
- Root · 12 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 11 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 10 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 9 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 8 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 7 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 6 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 5 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 4 generations backK050979 S4 Spinal SystemAesculap, Inc. · 2005
- 3 generations backK060152 Modification to S4 Spinal SystemAesculap, Inc. · 2006
- 2 generations backK103414 Venus Cervical Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2011
- 1 generation backK120879 Lexus Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2012
- This deviceK143278 LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2015
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2016 · cites it directly12descendants
- K200793LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2020 · cites it directly11descendants
- K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine · 2021 · 2 generations on10descendants
- K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc. · 2022 · 2 generations on6descendants
- K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc. · 2023 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −11 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −10 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −9 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −8 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −7 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −6 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −5 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −4 | K050979 | S4 Spinal System | Aesculap, Inc. | 2005 | — |
| −3 | K060152 | Modification to S4 Spinal System | Aesculap, Inc. | 2006 | — |
| −2 | K103414 | Venus Cervical Spinal Fixation System | L&K BIOMED Co., Ltd. | 2011 | — |
| −1 | K120879 | Lexus Cervical Fixation System | L&K BIOMED Co., Ltd. | 2012 | — |
| 0 (this device) | K143278 | LnK Posterior Cervical Fixation System | L&K BIOMED Co., Ltd. | 2015 | — |
| +1 | K162136 | CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical… | L&K BIOMED Co., Ltd. | 2016 | — |
| +1 | K200793 | LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical… | L&K BIOMED Co., Ltd. | 2020 | — |
| +2 | K210035 | ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System… | Aegis Spine | 2021 | — |
| +2 | K221050 | ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon… | Aegis Spine, Inc. | 2022 | — |
| +3 | K223719 | Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System | Aegis Spine, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 6 | 0 |
| 2024 | 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 KWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K120879 | Lexus Cervical Fixation SystemSummary page 4…e or legally marketed devices which are substantially equivalent Primary predicate: L&K BIOMED Co.,Ltd. / LnK Posterior Cervical Fixation System (K120879) 5. Description of the Device The LnK Posterior Cervical Fixation System is a top-loading, multiple component, post… | 2012 |
What descends from it? (13)
See all 133 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 30 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 23 ancestors has a recall of any class.
- Of its descendants, K162136 (L&K BIOMED Co., Ltd., 2016) has gone furthest, with 12 descendants of its own.
- 3 other devices also cite its predicate K120879.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The LnK Posterior Cervical Fixation System is indicated for the following: - DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) - Spondylolisthesis - Spinal stenosis - Fracture/dislocation - Failed previous fusion - Tumors The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of…
Read the full statement (129 words)
The LnK Posterior Cervical Fixation System is indicated for the following:
- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- Spondylolisthesis
- Spinal stenosis
- Fracture/dislocation
- Failed previous fusion
- Tumors
The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of fractures/dislocations or trauma in the spine.
Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (CI-T3) spine.
The pedicle screws are limited to placement in T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143278 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143278: LnK Posterior Cervical Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143278
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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