# K221502: Parcus Synd-EZ SS

- Pathway: 510(k) (Traditional)
- Applicant: Parcus Medical, LLC
- Decided: Jul 26, 2022 after 64 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: 13 generations back to K792022 (1979). 59 ancestors in all.
No later device cites it as a predicate yet.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191783: Parcus Synd-EZ Ti, Parcus Medical, LLC (2019) Summary page 4.
- K192964: Parcus Synd-EZ SS, Parcus Medical, LLC (2019) Summary page 4.

## Indications for use
The Parcus Synd-EZ SS 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 SS 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/K221502
Methodology: https://510kreport.com/methodology