# K181799: ResCUBE™ Ligament Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Cousin Biotech Sas
- Decided: Aug 29, 2018 after 55 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). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 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.
- K922952: Songer Cable System, Pioneer Surgical Technology (1993) Summary page 4.
- K941213: Songer Cable System, Pioneer Surgical Technology (1994) Summary page 4.
- K153348: Jazz Lock, Implanet, S.A. (2016) Summary page 4.

## Indications for use
The ResCUBE 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, that can be treated with sublaminar, interspinous or facet wiring techniques. 2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as scoliosis, kyphosis and spondylolisthesis. 3. Spinal degenerative surgery, as an adjunct to spinal fusions.

Source page: https://510kreport.com/device/K181799
Methodology: https://510kreport.com/methodology