# K172206: NAJA™ Ligament Correction System

- Pathway: 510(k) (Traditional)
- Applicant: Cousin Biotech Sas
- Decided: Apr 10, 2018 after 263 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: 6 generations back to K925812 (1993). 27 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110348: Universal Clamp Spinal Fixation System, Zimmer Spine (2011) Summary page 4.
- K922952: Songer Cable System, Pioneer Surgical Technology (1993) Summary page 4.

## Most influential descendants
- K200281: The Gecko Spinal System (2020), 0 descendants of its own
- K181799: ResCUBE™ Ligament Fixation System (2018), 0 descendants of its own

## Indications for use
The NAJA 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 NAJA System may also be used in conjunction with other medical grade implants made of titanium or cobalt chrome alloy whenever “wiring” may help secure the attachment of the other implants.

Source page: https://510kreport.com/device/K172206
Methodology: https://510kreport.com/methodology