# K193606: Y-Knot OneStep Anchor

- Pathway: 510(k) (Special)
- Applicant: Conmed Corporation
- Decided: Jan 22, 2020 after 30 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: 11 generations back to K911837 (1991). 80 ancestors in all.
No later device cites it as a predicate yet.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131035: Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MM, Linvatec Corporation D/B/A Conmed Linvatec (2013) Summary page 4.

## Indications for use
The non-absorbable implant is intended to reattach soft tissue to bone in orthopedic surgical procedures. The devices may be used in either arthroscopic or open surgical procedures. After suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

Source page: https://510kreport.com/device/K193606
Methodology: https://510kreport.com/methodology