Cleared Special

Freedom Ultra-Congruent CR Tibial Liner

K182574 · Maxx Orthopedics, Inc. · Orthopedic

Jan 2019

Decision

126d

Days

Class 2

Risk

About This 510(k) Submission

K182574 is an FDA 510(k) clearance for the Freedom Ultra-Congruent CR Tibial Liner, 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 January 22, 2019, 126 days after receiving the submission on September 18, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K182574 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 18, 2018
Decision Date	January 22, 2019
Days to Decision	126 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