# K092765: Lanx Anterior Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Lanx, Inc.
- Decided: Apr 7, 2010 after 210 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: 4 generations back to K922543 (1993). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922543: Z-Plate Anterior Fixation System, Sofamor Danek Mfg., Inc. (1993) Summary page 1.
- K982875: Modification to Zplate-Atl Anterior Fixation System, Danek Medical, Inc. (1999) Summary page 1.
- K043548: Blackstone Unity Anterior Lumbar Plate Fixation System, Blackstone Medical, Inc. (2005) Summary page 1.
- K061229: Unity LX Anterolateral Lumbar Plate Fixation System, Blackstone Medical, Inc. (2006) Summary page 1.
- K022791: Synthes Anterior Tension Band (Atb) System, Synthes (Usa) (2002) Summary page 1.

## Most influential descendants
- K202309: Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion System (2020), 0 descendants of its own

## Indications for use
The Lanx Anterior Plating System is intended to provide fixation of the thoracic, lumbar and/or sacral spine (T1-S1) as an adjunct to fusion using autograft or allograft in skeletally mature patients in the treatment of the following instabilities or deformities: * Degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), * Spinal stenosis (indicated for L1-S1 only); * Spondylolisthesis; * Deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis); * Trauma (i.e., fracture, dislocation, or subluxation); * Spondylolysis; * Tumor; * Pseudoarthrosis; and/or * Failed previous fusion. The Lanx Anterior Plating System is indicated for use via the lateral or anterolateral surgical approach for fixation of the thoracic and thoracolumbar spine, or via the anterior surgical approach for fixation of the lumbosacral spine below the bifurcation of the great vessels.

Source page: https://510kreport.com/device/K092765
Methodology: https://510kreport.com/methodology