# 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

- Pathway: 510(k) (Traditional)
- Applicant: Parcus Medical, LLC
- Decided: Oct 28, 2020 after 79 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). 73 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 76 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.
- K183331: Parcus GFS BTB, Parcus Medical, LLC (2019) Summary page 4.
- K190375: Parcus ATLAS, Parcus Medical, LLC (2019) Summary page 4.
- K191783: Parcus Synd-EZ Ti, Parcus Medical, LLC (2019) Summary page 4.
- K192750: AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip, Parcus Medical, LLC (2020) Summary page 4.

## Most influential descendants
- 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 II and GFS Mini are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. The Parcus GFS Naked devices are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. The GFS Ultimate devices are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. The GFS BTB devices are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair The Parcus ATLAS is indicated for adjunct fixation of the 1st and 2nd metacarpals in CMC arthroplasty. The Parcus Actiflip Naked, Actiflip Cinch, and Actiflip Whip are 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. The Parcus Synd-EZ Ti are 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 Ti are 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/K202259
Methodology: https://510kreport.com/methodology