# K180728: Spinal Elements Cerclage System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Elements, Inc.
- Decided: Sep 6, 2018 after 170 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: 2 generations back to K922952 (1993). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153348: Jazz Lock, Implanet, S.A. (2016) Summary page 5.

## Most influential descendants
- K190289: Karma® Fixation System (2019), 0 descendants of its own

## Indications for use
The Spinal Elements Cerclage System is intended for use in cardiovascular surgery. The indications for use include cardiovascular surgery for closure of the sternum following sternotomy. The system is intended to provide temporary stabilization during the development of solid bony fusion. The Spinal Elements Cerclage System is a temporary implant to be used in orthopedic surgery. The Spinal Elements Cerclage System is a bony anchor designed to provide temporary stabilization of the spine for bony fusion or consolidation of a fracture. The Spinal Elements Cerclage System is designed for a posterior approach. The indications for use include the following applications: 1. Spinal trauma surgery: The Spinal Elements Cerclage implants can be used in sublaminar wiring techniques; 2. Spinal degenerative surgery: The Spinal Elements Cerclage implants may be used as an adjunct to spinal fusions with bone graft (autograft or allograft) at level(s) of use.

Source page: https://510kreport.com/device/K180728
Methodology: https://510kreport.com/methodology