Cleared Traditional

K173057 - Zimmer Knee Joint Replacement Prostheses MR Labeling

K173057 is an FDA 510(k) clearance for Zimmer Knee Joint Replacement Prosthese..., manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K173057 · Zimmer, Inc. · Orthopedic device
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Mar 2018
Decision
182d
Days
Class 2
Risk

K173057 is an FDA 510(k) clearance for the Zimmer Knee Joint Replacement Prostheses MR Labeling. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 29, 2018 after a review of 182 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 Zimmer, Inc. devices

FDA 510(k) Submission Details - K173057

510(k) Number K173057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2017
Decision Date March 29, 2018
Days to Decision 182 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
60d slower than avg
Panel avg: 122d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWH Device Classification - Class 2, Special Controls

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 887
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K173057.
Balanced Knee Revision System - Offset Junction Box
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Conformis iTotal Cruciate Retaining (CR) Knee Replacement System
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World Knee System
K180750 · Signature Orthopaedics Pty, Ltd. · Apr 2018
Acculoc Total Knee System
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Klassic® Knee System
K180159 · Total Joint Orthopedics, Inc. · Mar 2018
EMPOWR Universal Tibial Baseplate
K173723 · Encore Medical, L.P. · Mar 2018