# K143278: LnK Posterior Cervical Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: L&K BIOMED Co., Ltd.
- Decided: Jul 29, 2015 after 257 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K853033 (1985). 23 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120879: Lexus Cervical Fixation System, L&K BIOMED Co., Ltd. (2012) Summary page 4.

## Most influential descendants
- K162136: CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System (2016), 12 descendants of its own
- K200793: LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System (2020), 11 descendants of its own
- K210035: ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System (2021), 10 descendants of its own
- K221050: ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System (2022), 6 descendants of its own
- K223719: Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System (2023), 3 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K143278
Methodology: https://510kreport.com/methodology