# K182808: Aspida® Anterior Lumbar Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Nov 9, 2018 after 37 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: 7 generations back to K922543 (1993). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101255: Alphatec Spine Anterior Lumbar Plating System, Alphatec Spine, Inc. (2010) Summary page 4.
- K090222: Pioneer Lumbar Plate System, Pioneer Surgical Technology (2009) Summary page 4.

## Most influential descendants
- K230721: ATEC Lateral Plate System (2023), 0 descendants of its own

## Indications for use
The AVSLGD Anterior Lumbar Plating System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach below the bifurcation of the great vessels. The device is intended as a temporary fixation device until fusion is achieved. The AVSLGD Anterior Lumbar Plating System is intended for anterior lumbar spine (L1-S1) fixation for the following indications: 1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies) 2. Pseudoarthrosis 3. Spondylolysis 4. Spondylolisthesis 5. Trauma (i.e., fracture or dislocation) 6. Spinal stenosis 7. Unsuccessful previous fusion surgery 8. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) 9. Tumor

Source page: https://510kreport.com/device/K182808
Methodology: https://510kreport.com/methodology