# K220797: FootHold System

- Pathway: 510(k) (Traditional)
- Applicant: Crossroads Extremity Systems, LLC
- Decided: Apr 15, 2022 after 28 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: 5 generations back to K961555 (1996). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153585: Flip Button Suture Anchor, First Ray, LLC (2016) Summary page 4.

## Indications for use
FootHold™ System 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/K220797
Methodology: https://510kreport.com/methodology