# K120879: Lexus Cervical Fixation System

- Pathway: 510(k) (Special)
- Applicant: L&K BIOMED Co., Ltd.
- Decided: May 23, 2012 after 61 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K853033 (1985). 22 ancestors in all.
15 later devices descend from it; 4 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031985: Spinal Concepts Inc. Nex-Link Spinal Fixation System, Spinal Concepts, Inc. (2003) Summary page 1.
- K050979: S4 Spinal System, Aesculap, Inc. (2005) Summary page 1.
- K060152: Modification to S4 Spinal System, Aesculap, Inc. (2006) Summary page 1.
- K003780: Vertex Reconstruction System, Medtronic Sofamor Danek, Inc. (2001) Summary page 1.
- K103414: Venus Cervical Spinal Fixation System, L&K BIOMED Co., Ltd. (2011) Summary page 1.

## Most influential descendants
- K143278: LnK Posterior Cervical Fixation System (2015), 13 descendants of its own
- 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

## Indications for use
The LEXUS 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 stenrosis * 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 (ClI -T3) spine. The pedicle screws are limited to placement in TI -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/K120879
Methodology: https://510kreport.com/methodology