Federal Register #FDA-2026-N-6708

FDA Classifies Medial Knee Implanted Shock Absorber (MISHA Knee System) as Class II Device

This summary covers the FDA's final order classifying a new orthopedic device: - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - Moximed, Inc. (submitted De Novo classification request for the MISHA Knee System) - Products/Services Requested: - Medial knee implanted shock absorber - Device implanted outside the knee capsule, extending from the distal femur to the proximal tibia - Biomechanically stabilized by plates and screws - Intended to reduce loads on the intra-articular medial joint surface to improve osteoarthritis symptoms - No specific part numbers or purchase quantities provided - Unique or Notable Requirements: - Device classified as Class II with special controls under 21 CFR 888.3610 - Requirements include: - Clinical data demonstrating safety and effectiveness - Non-clinical performance testing - Biocompatibility and sterility validation - Reprocessing validation and shelf-life support - User training and specific labeling - Classification is intended to enhance patient access and reduce regulatory burdens - No procurement or solicitation for products or services is present in this notice

Description

The Food and Drug Administration (FDA) is classifying the medial knee implanted shock absorber into class II (special controls). This device is implanted outside the knee capsule and is intended to reduce loads on the intra-articular medial joint surface to improve symptoms of osteoarthritis. The classification aims to provide reasonable assurance of safety and effectiveness, reduce regulatory burdens, and enhance patient access to innovative devices. Special controls include clinical data, non-clinical performance testing, biocompatibility, sterility, reprocessing validation, shelf-life support, training programs, and specific labeling requirements.

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