# K002406: Mitek 2GII Meniscal Repair System

- Pathway: 510(k) (Traditional)
- Applicant: Mitek Products
- Decided: Feb 15, 2001 after 192 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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 K970119 (1998). 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)
- K970119: Mitek Absorbable Polydioxanone (PDS) H Fix, Mitek Products (1998) Summary page 1.
- (no number) PDS Absorbable Suture: named in the summary without a submission number

## Most influential descendants
- K023388: Mitek Rapidloc-PDS Meniscal Repair System (2002), 2 descendants of its own
- K092836: Omnispan Meniscal Repair System/0 Degree, Model 228140, Rapidloc A2 Meniscal Repair System/12 Degree, Model 228141 (2010), 0 descendants of its own
- K082518: Dual Needle Suture Passer System (2009), 0 descendants of its own
- K053492: Bioduct (2007), 0 descendants of its own

## Indications for use
The Mitek RapidLoc™ Meniscal Repair System is intended for use in the arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle lesions) located in the vascularized area of the meniscus (red-red and red-white zones).

Source page: https://510kreport.com/device/K002406
Methodology: https://510kreport.com/methodology