Cleared Traditional

FREEDOM PCK COMPONENTS

K131481 · Maxx Orthopedics, Inc. · Orthopedic

Feb 2014

Decision

275d

Days

Class 2

Risk

About This 510(k) Submission

K131481 is an FDA 510(k) clearance for the FREEDOM PCK COMPONENTS, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Maxx Orthopedics, Inc. (Plymouth Meeting, US). The FDA issued a Cleared decision on February 21, 2014, 275 days after receiving the submission on May 22, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K131481 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 22, 2013
Decision Date	February 21, 2014
Days to Decision	275 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