Cleared Traditional

MedalOne Total Knee System (K244039) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K244039 · Suzhou Microport Orthorecon Co., Ltd. · Orthopedic device
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Feb 2025
Decision
60d
Days
Class 2
Risk

K244039 is an FDA 510(k) clearance for the MedalOne Total Knee System. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Suzhou Microport Orthorecon Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on February 28, 2025 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Suzhou Microport Orthorecon Co., Ltd. devices

Submission Details

510(k) Number K244039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2024
Decision Date February 28, 2025
Days to Decision 60 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 122d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
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.

Regulatory Peers - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 542
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K244039.
Klassic Knee System - Revision Tibial Baseplate
K243991 · Total Joint Othopedics, Inc. · Mar 2025
Freedom Total Knee System (All-poly Tibial Plate)
K250382 · Maxx Orthopedics, Inc. · Mar 2025
Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)
K243724 · Zimmer, Inc. · Mar 2025
Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique
K243574 · Microport Orthopedics, Inc. · Feb 2025
Scorpio Universal Dome Patella
K243817 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Feb 2025
Consensus Knee System with TiNbN
K241180 · Shalby Advanced Technologies · Jan 2025