# K212739: ActiFlip

- Pathway: 510(k) (Traditional)
- Applicant: Parcus Medical, LLC
- Decided: Oct 6, 2021 after 37 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: 14 generations back to K792022 (1979). 122 ancestors in all.
No later device cites it as a predicate yet.
0 of 123 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192750: AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip, Parcus Medical, LLC (2020) Summary page 4.
- 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, Parcus Medical, LLC (2020) Summary page 4.
- K111000: Parcus 2.0MM / 2.5MM / 3.5MM Miti Titanium Suture Anchor, Parcus Medical, LLC (2011) Summary page 4.
- K201083: Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors, Parcus Medical, LLC (2020) Summary page 4.

## Indications for use
The Parcus Actiflip is used for fixation of bone to bone or soft tissue to bone, and is intended as a 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 ActiFlip is also intended for fixation of suture (soft tissue) to bone in the foot and ankle for midfoot reconstruction and hindfoot reconstruction with the following procedures: FHL Tendon Transfer, FDL Tendon Transfer, Posterior Tibialis Tendon Transfer, Anterior Tibialis Tendon Transfer.

Source page: https://510kreport.com/device/K212739
Methodology: https://510kreport.com/methodology