# K110789: Synthes Sternal Zipfix System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jul 28, 2011 after 128 days
- Product code: JDQ (Cerclage, Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3010
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K931271 (1994). 3 ancestors in all.
85 later devices descend from it; 6 cite it directly.
0 of 89 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 1.
- K946173: Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly (Ethylene Terephthalate) and Silk, ETHICON, Inc. (1995) Summary page 1.
- K093772: Synthes Sternal Fixation System, Synthes (2010) Summary page 1.

## Most influential descendants
- K111908: Biomet Microfixation Sternal Closure System (2011), 78 descendants of its own
- K121302: Biomet Microfixation Sternal Closure System (2012), 75 descendants of its own
- K151983: KLS Martin LSS Plating System (2016), 45 descendants of its own
- K151019: SternaLock® 360 Sternal Closure System (2015), 43 descendants of its own
- K163007: Biomet Microfixation SternaLock 360 Sternal Closure System (2016), 40 descendants of its own

## Recalls of this device
- Oct 19, 2015 · Class II · Z-0276-2016: Certain lots of the Application Instrument for Sternal ZIPFIX that were previously recalled on August 19, 2015 and subsequently repaired and returned to customers between August 26, 2015 and September
- Jul 22, 2015 · Class II · Z-2475-2015: The end cap may loosen and detach making the instrument non-functional. No injuries reported.
- Aug 13, 2013 · Class II · Z-0114-2014: When using the 1st generation Zip Fix Application Instrument it is possible to cut the implant while the tensioning trigger is being squeezed which could lead to loosening of the implant.

## Indications for use
The Synthes Sternal ZipFixTM System is intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.

Source page: https://510kreport.com/device/K110789
Methodology: https://510kreport.com/methodology