# K253763: Y-Knotless™ Flex Anchors

- Pathway: 510(k) (Special)
- Applicant: Conmed Corporation
- Decided: Jan 29, 2026 after 65 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.
1 later device descends from it; 1 cites it directly.
0 of 82 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 5.

## Most influential descendants
- K261363: Y-Knotless™ Flex Anchors (2026), 0 descendants of its own

## Indications for use
The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The Y-Knotless TM Flex Anchors 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 systems thereby stabilize the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period. The Y-Knotless™ Flex Anchors may be used in the following orthopedic procedures: 1. Shoulder Labrum 2. MPFL Reconstruction 3. Foot and Ankle 4. Biceps 5. Meniscal Root Repair

Source page: https://510kreport.com/device/K253763
Methodology: https://510kreport.com/methodology