# K192750: AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip

- Pathway: 510(k) (Traditional)
- Applicant: Parcus Medical, LLC
- Decided: Jan 16, 2020 after 108 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: 12 generations back to K792022 (1979). 69 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133757: GFS II Standard, GFS II Large, GFS Mimi, Parcus Medical, LLC (2014) Summary page 4.
- K152711: Parcus GFS Naked, Parcus Medical, LLC (2015) Summary page 4.
- K162198: GFS Ultimate, Parcus Medical, LLC (2016) Summary page 4.
- K190288: Arthrex Tenodesis Button, Arthrex, Inc. (2019) 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 AcTiFlip is used for fixation of bone to bone or soft tissue to bone, and is intended as fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include the following indications; anterior cruciate ligament, posterior cruciate ligament, pectoralis repair (minor/major), biceps tendon repair and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction. The Parcus GFS Ultimate Hip is used for fixation of soft tissue to bone in the hip and is indicated for ligamentum teres reconstruction.

Source page: https://510kreport.com/device/K192750
Methodology: https://510kreport.com/methodology