# K191783: Parcus Synd-EZ Ti

- Pathway: 510(k) (Special)
- Applicant: Parcus Medical, LLC
- Decided: Oct 9, 2019 after 98 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K792022 (1979). 57 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162198: GFS Ultimate, Parcus Medical, LLC (2016) Summary page 4.
- K043248: Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DS, Arthrex, Inc. (2005) Summary page 4.

## Most influential descendants
- K202259: Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip (2020), 2 descendants of its own
- K192964: Parcus Synd-EZ SS (2019), 1 descendant of its own
- K213018: Auxilock GFS Mini, GFS II Large, and GFS Ultimate (2022), 0 descendants of its own
- K221502: Parcus Synd-EZ SS (2022), 0 descendants of its own
- K212739: ActiFlip (2021), 0 descendants of its own

## Indications for use
The Parcus Synd-EZ Ti is intended to be used as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. The Parcus Synd-EZ Ti is intended to provide fixation during the healing process following syndesmotic trauma, such as fixation of the syndesmosis (syndesmosis disruptions) in connection with Weber B and Weber C ankle fractures.

Source page: https://510kreport.com/device/K191783
Methodology: https://510kreport.com/methodology