# K131035: Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MM

- Pathway: 510(k) (Special)
- Applicant: Linvatec Corporation D/B/A Conmed Linvatec
- Decided: Jul 2, 2013 after 81 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: 10 generations back to K911837 (1991). 79 ancestors in all.
17 later devices descend from it; 4 cite it directly.
0 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111779: Y-Knot All-Suture Anchor Model HF13, Conmed Linvatec (2011) Summary page 2.

## Most influential descendants
- K133224: Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2 Hifi Sutures (2014), 12 descendants of its own
- K192709: Fixone All Suture Anchor (2020), 3 descendants of its own
- K233429: OTS 25 (100-1) (2023), 2 descendants of its own
- K253763: Y-Knotless™ Flex Anchors (2026), 1 descendant of its own
- K241234: OTS 25-L (100-5) (2025), 1 descendant of its own

## Indications for use
The device is intended to reattach soft tissue to bone in orthopedic surgical procedures. The device may be used in either arthroscopic or open surgical procedures. After the 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/K131035
Methodology: https://510kreport.com/methodology