# K090923: Parcus Graft Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Parcus Medical, LLC
- Decided: Jun 30, 2009 after 90 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: 9 generations back to K792022 (1979). 55 ancestors in all.
21 later devices descend from it; 2 cite it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980155: Endobutton Continuous Loop, Smith & Nephew, Inc. (1998) Summary page 1.
- K081098: Endobutton Continuous Loop (CL), Smith & Nephew Inc., Endoscopy Division (2008) Summary page 1.
- K070780: Conmed Linvatec XO Button, Conmed Linvatec (2007) Summary page 1.

## Most influential descendants
- K133757: GFS II Standard, GFS II Large, GFS Mimi (2014), 16 descendants of its own
- K160655: OrthoButton CL (2016), 9 descendants of its own
- K171060: OrthoButton AL (2017), 8 descendants of its own
- K162198: GFS Ultimate (2016), 8 descendants of its own
- K191783: Parcus Synd-EZ Ti (2019), 5 descendants of its own

## Indications for use
The Parcus GFS is indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.

Source page: https://510kreport.com/device/K090923
Methodology: https://510kreport.com/methodology