# K121060: Spine Frontier Indus Acp System

- Pathway: 510(k) (Special)
- Applicant: Spinefrontier, Inc.
- Decided: Jul 3, 2012 after 88 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K002592 (2000). 11 ancestors in all.
15 later devices descend from it; 3 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093776: Indus Anterior Cervical Plate System, Spinefrontier, Inc. (2010) Summary page 1.
- K050588: Verteview Anterior Cervical Plate System, Innovative Spinal Design, LLC (2005) Summary page 1.
- K073275: Nuvasive Helix Mini Acp System, Nuvasive, Inc. (2008) Summary page 1.
- K030866: Synthes Anterior CSLP System, Synthes (Usa) (2003) Summary page 1.

## Most influential descendants
- 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
- K231251: FlexWing Anterior Cervical Plate System (2024), 2 descendants of its own

## Recalls of this device
- Nov 20, 2013 · Class II · Z-0574-2014: Mismarked and unmarked screws
- Nov 20, 2013 · Class II · Z-0575-2014: Mismarked and unmarked screws
- Nov 20, 2013 · Class II · Z-0573-2014: Mismarked and unmarked screws
- Nov 20, 2013 · Class II · Z-0576-2014: Mismarked and unmarked screws
- Jun 21, 2013 · Class II · Z-1933-2013: Difficulty removing screws from the Invue caddies.
- May 9, 2012 · Class II · Z-1957-2013: The nipple of the tipped driver broke off when surgeons were attempting to insert the screw.

## Indications for use
The SpineFrontier Indus ACP System (Indus InVue, Indus InVue 2, Indus Inset) 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 C2 to T1. 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/K121060
Methodology: https://510kreport.com/methodology