Cleared Traditional

K161705 - U2 Total Knee System E-XPE products

K161705 is the FDA 510(k) clearance for U2 Total Knee System E-XPE products by United Orthopedic Corporation. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K161705 · United Orthopedic Corporation · Orthopedic device
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Mar 2017
Decision
269d
Days
Class 2
Risk

K161705 is an FDA 510(k) clearance for the U2 Total Knee System E-XPE products. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by United Orthopedic Corporation (Hsinchu, TW). The FDA issued a Cleared decision on March 16, 2017 after a review of 269 days - an extended review 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: 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 United Orthopedic Corporation devices

Submission Details

510(k) Number K161705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2016
Decision Date March 16, 2017
Days to Decision 269 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
147d slower than avg
Panel avg: 122d · This submission: 269d
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 781
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K161705.
Smith & Nephew VISIONAIRE Adaptive Guides
K170282 · Smith & Nephew, Inc. · May 2017
ANTHEM CR Total Knee System
K170648 · Smith & Nephew, Inc. · May 2017
Exactech® Truliant™ Line Extensions
K171045 · Exactech, Inc. · Apr 2017
GMK Sphere
K162035 · Medacta International S.A. · Mar 2017
EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions
K162026 · Microport Orthopedics, Inc. · Mar 2017
Truliant Femoral Components
K170240 · Exactech, Inc. · Feb 2017