# K162386: KATOR Suture Anchor

- Pathway: 510(k) (Special)
- Applicant: Kator, LLC
- Decided: Oct 25, 2016 after 61 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: 4 generations back to K990987 (2000). 5 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152236: KATOR Suture Anchor, Kator, LLC (2015) Summary page 4.

## Most influential descendants
- K173269: KATOR Suture Anchor (2018), 2 descendants of its own
- K242477: Shoulder Soft Tissue Anchors (2025), 0 descendants of its own
- K182736: OIC Suture Anchor System (2018), 0 descendants of its own

## Indications for use
The KATOR Suture Anchor is intended for fixation of suture to bone in rotator cuff repairs and Achilles tendon repairs.

Source page: https://510kreport.com/device/K162386
Methodology: https://510kreport.com/methodology