# K200281: The Gecko Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corporation
- Decided: Mar 31, 2020 after 56 days
- Product code: OWI (Bone Fixation Cerclage, Sublaminar)
- Device class: 2
- Regulation: 21 CFR 888.3010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K925812 (1993). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172206: NAJA™ Ligament Correction System, Cousin Biotech Sas (2018) Summary page 4.
- K142053: Universal Clamp Spinal Fixation System, Zimmer Spine, Inc. (2014) Summary page 4.

## Indications for use
The Gecko Spinal System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: 1. Spinal trauma surgery, used in sublaminar or facet wiring techniques; 2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis and spondylolisthesis; 3. Spinal degenerative surgery, as an adjunct to spinal fusions. The Gecko Spinal System may also be used in conjunction with other Ortho Development’s spinal rod systems made of similar metals whenever “wiring” may help secure the attachment of the other implants.

Source page: https://510kreport.com/device/K200281
Methodology: https://510kreport.com/methodology