# K092836: Omnispan Meniscal Repair System/0 Degree, Model 228140, Rapidloc A2 Meniscal Repair System/12 Degree, Model 228141

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Mitek, A Johnson & Johnson Company
- Decided: Feb 4, 2010 after 142 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: 3 generations back to K970119 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002406: Mitek 2GII Meniscal Repair System, Mitek Products (2001) Summary page 2.
- K023388: Mitek Rapidloc-PDS Meniscal Repair System, Mitek Worldwide (2002) Summary page 2.

## Indications for use
The proposed OMNISPAN Meniscal Repair System is intended for use in the arthroscopic fixation of soft tissue procedures such as meniscal repair.

Source page: https://510kreport.com/device/K092836
Methodology: https://510kreport.com/methodology