# K992611: Mitek Rotator Cuff Quickanchor Plus

- Pathway: 510(k) (Traditional)
- Applicant: Mitek Products
- Decided: Sep 22, 1999 after 49 days
- Product code: HWC (Screw, Fixation, Bone)
- 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: 1 generation back to K915889 (1992). 1 ancestor in all.
4 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915889: Mitek Bone Anchor, Modification, Mitek Surgical Products, Inc. (1992) Summary page 1.

## Most influential descendants
- K052630: Rotator Cuff Quickanchor Plus (with Orthocord Suture) (2005), 2 descendants of its own
- K111631: Gil Anchor / Gil Quick Anchor Plus, Healix TI Dual Threaded Suture Anchor, Rotator Cuff Anchor / Rotator Cuff Quick an.. (2011), 1 descendant of its own
- K112417: Various (2012), 0 descendants of its own
- K993575: Resolve Quickanchor (1999), 0 descendants of its own

## Indications for use
The Mitek Rotator Cuff QuickAnchor® Plus is indicated for Rotator cuff repair.

Source page: https://510kreport.com/device/K992611
Methodology: https://510kreport.com/methodology
