# K162198: GFS Ultimate

- Pathway: 510(k) (Special)
- Applicant: Parcus Medical, LLC
- Decided: Nov 18, 2016 after 105 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: 10 generations back to K792022 (1979). 56 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090923: Parcus Graft Fixation System, Parcus Medical, LLC (2009) Summary page 4.

## Most influential descendants
- K191783: Parcus Synd-EZ Ti (2019), 5 descendants of its own
- K192750: AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip (2020), 3 descendants of its own
- K183331: Parcus GFS BTB (2019), 3 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K162198
Methodology: https://510kreport.com/methodology