Not Cleared Direct

DEN220033 - MISHA Knee System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN220033 · Moximed, Inc. · Orthopedic device
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Apr 2023
Decision
308d
Days
Class 2
Risk

DEN220033 is an FDA 510(k) submission (not cleared) for the MISHA Knee System. Classified as Medial Knee Implanted Shock Absorber (product code QVV), Class II - Special Controls.

Submitted by Moximed, Inc. (Fremont, US). The FDA issued a Not Cleared (DENG) decision on April 10, 2023 after a review of 308 days.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3610 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 308 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Moximed, Inc. devices

Submission Details

510(k) Number DEN220033 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 06, 2022
Decision Date April 10, 2023
Days to Decision 308 days
Submission Type Direct
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
186d slower than avg
Panel avg: 122d · This submission: 308d
Pathway characteristics

Device Classification

Product Code QVV Medial Knee Implanted Shock Absorber
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3610
Definition 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 A Shock Absorbing Mechanical System And Is Biomechanically Stabilized By Plates And Screws. The Device Is Not Intended To Span The Lateral Knee.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.