# K140260: Skyhawk Lateral Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix, Inc.
- Decided: Jul 2, 2014 after 149 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: 8 generations back to K990745 (1999). 36 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080407: Blackstone SFS Parallel Rod Connectors, Blackstone Medical, Inc. (2008) Summary page 1.
- K023498: Modification to Blackstone Spinal Fixation System, Blackstone Medical, Inc. (2002) Summary page 1.
- K091071: Nuvasive Lateral Plate System, Nuvasive, Inc. (2009) Summary page 1.
- K061789: Lateral Plate System, Nuvasive, Inc. (2006) Summary page 1.
- K120092: Plymouth Thoracolumbar Plate System, Globus Medical, Inc. (2012) 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
- K210061: ProLift Lateral HELO Fixated (2021), 3 descendants of its own
- K160362: Z-Span Plate System (2016), 3 descendants of its own

## Indications for use
The SKYHAWK Lateral Plate System is intended to be used as a non-pedicle lateral or anterolateral fixation system in skeletally mature patients and is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic and lumbar spine. It may be used from levels T1 to L5 with the following indications: * Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); * Spondylolisthesis; * Spinal stenosis; * Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis); * Tumor; * Pseudoarthrosis; * Failed previous fusion; and * Trauma (i.e., fracture or dislocation).

Source page: https://510kreport.com/device/K140260
Methodology: https://510kreport.com/methodology