# K143392: Quattro Bolt Tenodesis Screw

- Pathway: 510(k) (Traditional)
- Applicant: Cayenne Medical, Inc.
- Decided: Jan 23, 2015 after 58 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: 7 generations back to K961555 (1996). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122314: Quatro Link Knotless Anchor with Inserter, 2.9MM-Peek Only, Cayenne Medical, Inc. (2012) Summary page 7.

## Indications for use
The Cayenne Medical, Inc. Quattro® Bolt Tenodesis Screws 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 Elbow, Wrist, and Hand Biceps tendon reattachment Ulnar or radial collateral ligament reconstruction Lateral epicondylitis repair Knee Extra-capsular repairs Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Patellar realignment and tendon repairs Illiotibial band tenodesis Foot and Ankle Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy

Source page: https://510kreport.com/device/K143392
Methodology: https://510kreport.com/methodology