Cleared Traditional

Libertas ? Taper Uncemented Femoral Stem

K183684 · Maxx Orthopedics, Inc. · Orthopedic

Aug 2019

Decision

238d

Days

Class 2

Risk

About This 510(k) Submission

K183684 is an FDA 510(k) clearance for the Libertas ? Taper Uncemented Femoral Stem, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Maxx Orthopedics, Inc. (Norristown, US). The FDA issued a Cleared decision on August 23, 2019, 238 days after receiving the submission on December 28, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K183684 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 28, 2018
Decision Date	August 23, 2019
Days to Decision	238 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LZO — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353