Cleared Special

K210961 - U2 Total Knee System

K210961 is the FDA 510(k) clearance for U2 Total Knee System by United Orthopedic Corporation. It is a Class 2 Orthopedic device (product code JWH) cleared through the Special 510(k) pathway after a 21-day FDA review.

K210961 · United Orthopedic Corporation · Orthopedic device
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Apr 2021
Decision
21d
Days
Class 2
Risk

K210961 is an FDA 510(k) clearance for the U2 Total Knee System, XPE Tibial Insert, PS PLUS. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by United Orthopedic Corporation (Hsinchu City, TW). The FDA issued a Cleared decision on April 21, 2021 after a review of 21 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all United Orthopedic Corporation devices

Submission Details

510(k) Number K210961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2021
Decision Date April 21, 2021
Days to Decision 21 days
Submission Type Special
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
101d faster than avg
Panel avg: 122d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

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 764
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K210961.
Identity Imprint Knee Replacement System
K210191 · Conformis, Inc. · May 2021
Genius / Genuin Total Knee System
K200765 · Biorad Medisys Pvt, Ltd. · May 2021
MOBIO Total Knee System
K210483 · B-One Ortho, Corp. · Apr 2021
Apex Knee System
K201611 · Omnilife Science · Apr 2021
Persona Revision Knee System
K210551 · Zimmer, Inc. · Mar 2021
iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement System
K210252 · Conformis, Inc. · Feb 2021