# K093776: Indus Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Spinefrontier, Inc.
- Decided: Mar 26, 2010 after 108 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: 3 generations back to K002592 (2000). 7 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073232: Indus Anterior Cervical Plate System, Model IM3XXX, Spinefrontier, Inc. (2008) Summary page 1.
- K030866: Synthes Anterior CSLP System, Synthes (Usa) (2003) Summary page 1.
- K052292: Spider Cervical Plating (SCP) System, X-Spine Systems, Inc. (2005) Summary page 1.
- K062831: Modification to Life Spine Neo Anterior Cervical Plate System, Life Spine (2006) Summary page 1.

## Most influential descendants
- K121060: Spine Frontier Indus Acp System (2012), 15 descendants of its own
- K153526: Pyrenees Cervical Plate System (2016), 6 descendants of its own
- K140234: Aspiron Acp System (2014), 6 descendants of its own
- K162664: Pyrenees Cervical Plate System (2016), 5 descendants of its own
- K182473: PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems (2018), 4 descendants of its own

## Indications for use
The Indusrm Anterior Cervical Plate System is intended for anterior spine fixation for use in providing temporary stabilization during the development of cervical spinal fusions. The levels of treatment range from 02 to Ti. Indications include symptomatic cervical spondylolisthesis, trauma (fracture or dislocation), spinal stenosis, deformities or curvatures (scoliosis, kyphosis and or lordosis), tumor, pseudoarthrosis, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), and re-operation for failed fusion or instability following surgery for above indications.

Source page: https://510kreport.com/device/K093776
Methodology: https://510kreport.com/methodology