Cleared Traditional

MPO Total Knee Systems MR Labeling (K152631) - FDA 510(k) Clearance

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

K152631 · Microport Orthopedics, Inc. · Orthopedic device
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Mar 2016
Decision
190d
Days
Class 2
Risk

K152631 is an FDA 510(k) clearance for the MPO Total Knee Systems MR Labeling. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Microport Orthopedics, Inc. (Arlington, US). The FDA issued a Cleared decision on March 23, 2016 after a review of 190 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3530 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Microport Orthopedics, Inc. devices

Submission Details

510(k) Number K152631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2015
Decision Date March 23, 2016
Days to Decision 190 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 122d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3530
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 - HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

All 51
Devices cleared under the same product code (HRY) and FDA review panel - the closest regulatory comparables to K152631.
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NanoOrtho NanoKnee® System
K190633 · Nanoortho, LLC · Dec 2019
EVOLUTION UNICONDYLAR KNEE SYSTEM
K100973 · Wrightmedicaltechnologyinc · Aug 2010
STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION
K082567 · Howmedica Osteonics Corp. · Oct 2008
TRIATHLON PKR SYSTEM
K071881 · Howmedica Osteonics Corp. · Oct 2007
DEPUY GCK TIBIAL COMPONENTS
K070267 · DePuy Orthopaedics, Inc. · Aug 2007