# K171228: Fiji Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Sportwelding GmbH
- Decided: Jan 19, 2018 after 268 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K050749 (2005). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063479: Arthrex Pushlock, Arthrex, Inc. (2006) Summary page 4.

## Most influential descendants
- K240288: SF Push- in Anchor (2024), 1 descendant of its own
- K260294: SF Push-in Anchor (2026), 0 descendants of its own

## Indications for use
The Fiji Anchor is intended to be used for suture or tissue fixation in the foot, ankle, hand, wrist, elbow, and shoulder. The Fiji Anchor is designed only to be inserted with the BoneWelder 150-W1 system. Specific indications are listed below: Elbow: Ulnar or Radial Collateral Ligament Reconstruction Shoulder: Bankart Repair, Capsular Shift or Capsulolabral Reconstruction 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, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction

Source page: https://510kreport.com/device/K171228
Methodology: https://510kreport.com/methodology