Cleared Traditional

Biomet Knee Joint Replacement Prostheses

K171054 · Biomet, Inc. · Orthopedic

Jul 2017

Decision

109d

Days

Class 2

Risk

About This 510(k) Submission

K171054 is an FDA 510(k) clearance for the Biomet Knee Joint Replacement Prostheses, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 28, 2017, 109 days after receiving the submission on April 10, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K171054 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	JWH — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3560