Cleared Traditional

Freedom Cementless Femoral Component

K150680 · Maxx Orthopedics, Inc. · Orthopedic

Jun 2015

Decision

101d

Days

Class 2

Risk

About This 510(k) Submission

K150680 is an FDA 510(k) clearance for the Freedom Cementless Femoral Component, a Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (Class II — Special Controls, product code MBH), submitted by Maxx Orthopedics, Inc. (Plymouth Meeting, US). The FDA issued a Cleared decision on June 26, 2015, 101 days after receiving the submission on March 17, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number	K150680 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 17, 2015
Decision Date	June 26, 2015
Days to Decision	101 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MBH — Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3565