# K153585: Flip Button Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: First Ray, LLC
- Decided: May 5, 2016 after 141 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: 4 generations back to K961555 (1996). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050749: Arthrex Tak Family, Arthrex, Inc. (2005) Summary page 5.
- K061863: Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family, Arthrex, Inc. (2006) Summary page 5.
- K030995: Minilok Quickanchor Plus, Mitek Worldwide (2003) Summary page 5.

## Most influential descendants
- K220797: FootHold System (2022), 0 descendants of its own

## Indications for use
The First Ray Flip Button Suture Anchor is intended to be used for suture or tissue fixation in the foot, ankle, hand, and wrist. Specific indications are listed below: Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP Joints for All Digits, Digital Tendon Transfers Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-Foot Reconstruction

Source page: https://510kreport.com/device/K153585
Methodology: https://510kreport.com/methodology