# K183331: Parcus GFS BTB

- Pathway: 510(k) (Special)
- Applicant: Parcus Medical, LLC
- Decided: Feb 7, 2019 after 66 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). 58 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 62 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.
- K133757: GFS II Standard, GFS II Large, GFS Mimi, Parcus Medical, LLC (2014) 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
- K213018: Auxilock GFS Mini, GFS II Large, and GFS Ultimate (2022), 0 descendants of its own
- K212739: ActiFlip (2021), 0 descendants of its own

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

Source page: https://510kreport.com/device/K183331
Methodology: https://510kreport.com/methodology