# K113509: Lexus Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: L&K BIOMED Co., Ltd.
- Decided: Jan 20, 2012 after 53 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K994239 (2000). 4 ancestors in all.
19 later devices descend from it; 4 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061002: Maxima Anterior Cervical Plate System, U&I Corp. (2006) Summary page 1.
- K031276: Synthes Anterior Cervical Locking Plate (Aclp) System, Synthes (Usa) (2003) Summary page 1.
- K994239: Zephir Anterior Cervical Plate System, Medtronic Sofamor Danek, Inc. (2000) Summary page 1.
- K030327: Zephir Anterior Cervical System, Medtronic Sofamor Danek (2003) Summary page 1.

## Most influential descendants
- K143271: CastleLoc-P Anterior Cervical Plate System (2015), 15 descendants of its own
- K190425: CastleLoc-P Anterior Cervical Plate System (2019), 13 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
- K143279: LnK Anterior Cervical Plate System (2015), 5 descendants of its own

## Indications for use
The LEXUS 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), * pseudarthrosis, * failed previous fusion, * spinal stenosis.

Source page: https://510kreport.com/device/K113509
Methodology: https://510kreport.com/methodology