# DEN220033: MISHA Knee System

- Pathway: De Novo (Direct)
- Applicant: Moximed, Inc.
- Decided: Apr 10, 2023 after 308 days
- Product code: QVV (Medial Knee Implanted Shock Absorber)
- Device class: 2
- Regulation: 21 CFR 888.3610
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The MISHATM Knee System is indicated for patients with medial compartment knee osteoarthritis that have failed to find relief in surgical and/or non-surgical treatment modalities and are still experiencing pain that interferes with activities of daily living and are also unwilling to undergo or ineligible for total knee replacement due to age or absence of advanced osteoarthritis.

Source page: https://510kreport.com/device/DEN220033
Methodology: https://510kreport.com/methodology