# K961094: Mitek Threaded Anchor (Modification)

- Pathway: 510(k) (Traditional)
- Applicant: Mitek Products
- Decided: Oct 3, 1996 after 203 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: 1 generation back to K945203 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945203: Mitek Thraded Anchor (Mta), Mitek Surgical Products, Inc. (1995) Summary page 1.

## Most influential descendants
- K963502: Csco Forehead Fixation System (1997), 0 descendants of its own

## Indications for use
The device is used to anchor suture intoc bone. The suture is subsequently used by the surgeon to reattach the repositioned/injured soft tissue to bone. The purpose of this 510(k) submission is to expand the indications to include the browlift procedure. The intended use is the same as the predicate device, i.e., suture, when used to approximate soft tissue to bone during a period of rehabilitation.

Source page: https://510kreport.com/device/K961094
Methodology: https://510kreport.com/methodology