# K082187: Biomet Anterior Lumbar Plate

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, L.P.
- Decided: Nov 13, 2008 after 101 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 K022791 (2002). 3 ancestors in all.
126 later devices descend from it; 2 cite it directly.
0 of 130 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022791: Synthes Anterior Tension Band (Atb) System, Synthes (Usa) (2002) Summary page 1.
- K061353: Trinica Anterior Lumbar Plate System, Zimmer Spine, Inc. (2006) Summary page 1.
- K033312: Ebi Top Loading Mas Spinal Fixation System, Ebi, L.P. (2004) Summary page 1.

## Most influential descendants
- K121791: Zou Anterior Lumbar Plate System (2012), 113 descendants of its own
- K182746: ATEC ALIF and LLIF Spacer System (2018), 110 descendants of its own
- K183705: IdentiTi Porous Ti Interbody System (2019), 99 descendants of its own
- K191311: ATEC Lateral Interbody System (2019), 78 descendants of its own
- K192938: Invictus™ Spinal Fixation System (2019), 69 descendants of its own

## Indications for use
The Anterior Lumbar Plate System is an anterior or antereolateral spinal fixation device indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels in the fusion of the lumbar or lumbosacral spine at levels LI through SI. The system is indicated for use in the temporary stabilization of the anterior spine during the development of solid spinal fusions in patients with degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma including fractures, tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudoarthrosis, spondyloysis, spondylolisthesis, stenosis and/or failed previous fusion.

Source page: https://510kreport.com/device/K082187
Methodology: https://510kreport.com/methodology