# K040401: Lanx Anterior Cervial Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Lanx, LLC
- Decided: Apr 12, 2004 after 55 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: 1 generation back to K993855 (1999). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993855: Atlantis Anterior Cervical Plate System, Danek Medical, Inc. (1999) Summary page 1.

## Most influential descendants
- K050774: Lanx Anterior Cervical Plate System (2005), 0 descendants of its own

## Indications for use
The Lanx Anterior Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The Lanx Anterior Cervical Plate System is suitable for use to provide temporary stabilization of the anterior spine while awaiting bony fusion (healing) in patients with degenerative disc disease (neck or radicular pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, lordosis or scoliosis), or pseudoarthrosis and/or failed previous fusion between and including cervical levels C2 and C7. Warning: This device is not cleared for screw attachment to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Source page: https://510kreport.com/device/K040401
Methodology: https://510kreport.com/methodology