Cleared Traditional

K171054 - Biomet Knee Joint Replacement Prostheses

K171054 is the FDA 510(k) clearance for Biomet Knee Joint Replacement Prostheses by Biomet, Inc.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K171054 · Biomet, Inc. · Orthopedic device
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Jul 2017
Decision
109d
Days
Class 2
Risk

K171054 is an FDA 510(k) clearance for the Biomet Knee Joint Replacement Prostheses. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 28, 2017 after a review of 109 days - within the typical 510(k) review window.

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 Biomet, Inc. devices

Submission Details

510(k) Number K171054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2017
Decision Date July 28, 2017
Days to Decision 109 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
13d faster than avg
Panel avg: 122d · This submission: 109d
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 K171054.
MyKnee PPS-Pin Positioners
K170106 · Medacta International S.A. · Oct 2017
3DMetal Tibial Cones
K170149 · Medacta International S.A. · Aug 2017
EVOLUTION Revision CCK System
K171389 · Microport Orthopedics, Inc. · Aug 2017
Genius Total Knee System
K170613 · Signature Orthopaedics Pty, Ltd. · Jul 2017
Empowr CR Knee Tibial Insert
K170573 · Encore Medical, L.P. · May 2017
Smith & Nephew VISIONAIRE Adaptive Guides
K170282 · Smith & Nephew, Inc. · May 2017