# K190333: Paradigm All-Suture Anchor 1.8mm, White/Black #2

- Pathway: 510(k) (Special)
- Applicant: Conmed Corporation
- Decided: Mar 18, 2019 after 32 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.
No later device cites it as a predicate yet.
0 of 80 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 4.

## Indications for use
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 systems thereby stabilize the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

Source page: https://510kreport.com/device/K190333
Methodology: https://510kreport.com/methodology