# K110541: Figure 8 Sternotomy Closure Device

- Pathway: 510(k) (Traditional)
- Applicant: Figure 8 Surgical, Incorporated
- Decided: Jul 6, 2011 after 131 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: 1 generation back to K931271 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
The Figure 8 Stemnotomy Closure Device is indicated for use in sternal closure procedures.

Source page: https://510kreport.com/device/K110541
Methodology: https://510kreport.com/methodology