# K120177: Spinal Elements Cerclage System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Elements, Inc.
- Decided: Jul 3, 2012 after 165 days
- Product code: JDQ (Cerclage, Fixation)
- 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 K931271 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931271: Ethi-Pack* Surgical Stainless Steel Suture, ETHICON, Inc. (1994) Summary page 2.
- K946173: Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly (Ethylene Terephthalate) and Silk, ETHICON, Inc. (1995) Summary page 2.
- K110789: Synthes Sternal Zipfix System, Synthes (Usa) (2011)

## Indications for use
The Spinal Elements Cerciage 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.

Source page: https://510kreport.com/device/K120177
Methodology: https://510kreport.com/methodology