Cleared Traditional

K183684 - Libertas – Taper Uncemented Femoral Stem

K183684 is the FDA 510(k) clearance for Libertas – Taper Uncemented Femoral Stem by Maxx Orthopedics, Inc.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K183684 · Maxx Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2019
Decision
238d
Days
Class 2
Risk

K183684 is an FDA 510(k) clearance for the Libertas – Taper Uncemented Femoral Stem. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Maxx Orthopedics, Inc. (Norristown, US). The FDA issued a Cleared decision on August 23, 2019 after a review of 238 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Maxx Orthopedics, Inc. devices

Submission Details

510(k) Number K183684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 122d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 433
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K183684.
MiniMAX
K192352 · Medacta International S.A. · Sep 2019
Signature Ceramic Femoral Head
K190704 · Signature Orthopaedics Pty, Ltd. · Aug 2019
BIOLOX CONTOURA Ceramic Femoral Head
K191399 · Total Joint Othopedics, Inc. · Aug 2019
Conformity Stem
K183312 · United Orthopedic Corporation · Aug 2019
BiMobile Dual Mobility System - E-Dur Inserts
K190535 · Waldemar Link GmbH & Co. KG · Aug 2019
Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System
K191781 · Zimmer GmbH · Aug 2019