510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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DEN220033Unknown

MISHA Knee System

Moximed, Inc., Fremont CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN220033 is the FDA 510(k) clearance record for MISHA Knee System, a class II device, cleared for Moximed, Inc. on under FDA product code QVV (Medial Knee Implanted Shock Absorber). FDA's definition for product code QVV reads: "A medial knee implanted shock absorber is a device implanted outside of the knee capsule extending from the distal femur to the proximal tibia. It is intended to reduce loads on the intra-articular medial joint surface. The device employs...". FDA records list one 510(k) clearance for Moximed, Inc. As of , FDA records show no recalls naming DEN220033.

Clearance record

Decision date
Received
(308 days to decision)
Product code
QVV Medial Knee Implanted Shock Absorber
Regulation
21 CFR 888.3610
Device class
Class II
Review panel
Orthopedic
Applicant
Moximed, Inc. 46602 Landing Pkwy., Fremont CA
Third party review
No

Clearances, product code QVV

Trailing 12 months

FDA records hold no clearances under product code QVV in the trailing twelve months.

FDA records show no clearances under product code QVV in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QVV, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260