# K180274: Ventix Link Knotless Anchor with Inserter

- Pathway: 510(k) (Traditional)
- Applicant: Cayenne Medical, Inc.
- Decided: Mar 21, 2018 after 49 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 K971723 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093897: Smith & Nephew Footprint Ultra PK Suture Anchor, Smith & Nephew Inc., Endoscopy Div. (2010) Summary page 4.

## Indications for use
The Cayenne Medical, Inc. Ventix™ Link Knotless Anchors are intended to be used for the reattachment of soft tissue to bone for the following indications: Shoulder • Acromioclavicular separation repairs • Deltoid repairs • Rotator cuff repairs • Biceps tenodesis Knee • Extra-capsular repairs o Medial collateral ligament o Lateral collateral ligament o Posterior oblique ligament • Patellar realignment and tendon repairs • Illiotibial band tenodesis • Supplementary fixation when used in conjunction with a primary fixation device in ACL repair and reconstruction surgical procedures requiring graft fixation. Foot and Ankle • Medial or lateral instability repairs/reconstructions • Achilles tendon repairs/reconstructions

Source page: https://510kreport.com/device/K180274
Methodology: https://510kreport.com/methodology