# K121791: Zou Anterior Lumbar Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Corelink, LLC
- Decided: Nov 19, 2012 after 153 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: 6 generations back to K922543 (1993). 14 ancestors in all.
113 later devices descend from it; 2 cite it directly.
0 of 128 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091044: Spinal Usa Anterior Lumbar Plate System, Spinal USA (2009) Summary page 2.
- K082187: Biomet Anterior Lumbar Plate, Ebi, L.P. (2008) Summary page 2.
- K061353: Trinica Anterior Lumbar Plate System, Zimmer Spine, Inc. (2006) Summary page 2.
- K022791: Synthes Anterior Tension Band (Atb) System, Synthes (Usa) (2002) Summary page 2.
- K052546: Aegis Anterior Lumbar Plate System, Depuy Spine, Inc. (2006) Summary page 2.

## Most influential descendants
- 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
- K202812: IdentiTi Cervical Standalone Interbody System (2020), 67 descendants of its own

## Indications for use
The CoreLink ZOUTM Anterior Lumbar Plate System is intended for use as an anteriorly placed supplemental fixation device via the lateral or anterior lateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. The CoreLink ZOUTM Anterior Lumbar Plate System is designed to provide temporary stability until fixation is achieved. It is intended for anterior lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Source page: https://510kreport.com/device/K121791
Methodology: https://510kreport.com/methodology