# K133194: Diamond Rattlesnake System

- Pathway: 510(k) (Traditional)
- Applicant: Eminent Spine
- Decided: Jun 26, 2014 after 252 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: 2 generations back to K061789 (2006). 7 ancestors in all.
17 later devices descend from it; 3 cite it directly.
0 of 25 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.
- K972718: M-2 Anterior Plate System, Acromed Corp. (1997) Summary page 1.
- K061789: Lateral Plate System, Nuvasive, Inc. (2006) Summary page 1.
- K082070: Nuvasive Lateral Plate System, Nuvasive, Inc. (2008) Summary page 1.
- K091071: Nuvasive Lateral Plate System, Nuvasive, Inc. (2009) Summary page 1.

## Most influential descendants
- K172131: 2 Hole Lateral Plating System (2017), 10 descendants of its own
- K180166: Life Spine Lumbar Fixation System (SENTRY) (2018), 9 descendants of its own
- K200338: ProLift Lateral Fixated (2020), 5 descendants of its own
- K162211: AccuFit Lateral Plate System (2016), 4 descendants of its own
- K220324: AccuFit Lateral 2-Hole Plate (2022), 3 descendants of its own

## Indications for use
The Eminent Spine Black Diamond Rattlesnake Lumbar Plating System is indicated for use via a lateral / anterolateral surgical approach above the great vessels in the treatment of the thoracolumbar spine (TI-Li). The Eminent Spine Red Diamond Rattlesnake Lumbar Plating System is indicated for use via an anterior surgical approach below the bifurcation of the great vessels in the treatment of the lumbosacral (LI-SI) spine. The Diamond Rattlesnake System is intended to provide temporary stabilization as an adjunct to fusion using a lateral approach in skeletally mature patients for the treatment of the following acute and chronic instabilities and deformities: degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudarthrosis, spondylolysis, spondylolisthesis, deformity (scoliosis, kyphosis, and or lordosis). spinal stenosis, fracture (including dislocation and subluxation), tumor, or failed previous spine surgery.

Source page: https://510kreport.com/device/K133194
Methodology: https://510kreport.com/methodology