Cleared Special

Freedom Primary PCK

K192148 · Maxx Orthopedics, Inc. · Orthopedic

Sep 2019

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K192148 is an FDA 510(k) clearance for the Freedom Primary PCK, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Maxx Orthopedics, Inc. (Norristown, US). The FDA issued a Cleared decision on September 5, 2019, 28 days after receiving the submission on August 8, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K192148 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 08, 2019
Decision Date	September 05, 2019
Days to Decision	28 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Statement

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