# K013334: Endoflip

- Pathway: 510(k) (Traditional)
- Applicant: Arthocare Corporation
- Decided: Dec 13, 2001 after 65 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Endoflip graft fixation device is intended for use in the fixation of ligament and tendon grafts in cruciate ligament reconstruction surgeries.

Source page: https://510kreport.com/device/K013334
Methodology: https://510kreport.com/methodology