# K221364: Mitek TIGHT-N Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Jul 11, 2022 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: 9 generations back to K961555 (1996). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201749: Arthrex SwiveLock Anchor, Arthrex, Inc. (2020) Summary page 4.

## Indications for use
The MITEK TIGHT-NTm Tendon Docking Anchor is indicated for use for reattachment of soft tissue to bone for the following procedures: * Shoulder: Biceps tenodesis * Knee: Medial patellofemoral ligament repair/reconstruction (MPFL), posterior oblique ligament repair (POL), medial collateral ligament (MCL) repair, lateral collateral ligament (LCL) repair, anterolateral ligament (ALL) reconstruction, Iliotibial (IT) Band Tenodesis

Source page: https://510kreport.com/device/K221364
Methodology: https://510kreport.com/methodology