De Novo · Granted
GrantedMISHA Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Moximed, Inc. · QVV Medial Knee Implanted Shock Absorber
Granted on Apr 10, 2023 as a new device type through De Novo after a 308-day review.
- Decided
- Apr 10, 2023
- Review
- 308 days
- Class
- Class II
- Product code
- QVV
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QVV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All QVV devicesQVV Medial Knee Implanted Shock Absorber: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QVV
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QVV
Too few QVV 510(k)s in any year since 2007 to give a median.
Recalls per year · QVV
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QVV
10in 2025
MAUDE reports naming product code QVV, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 1 | 3 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN220033 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN220033: MISHA Knee System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN220033
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026