Cleared Traditional

Maxx Libertas Bipolar Hip Head (Bipolar Hip)

K243634 · Maxx Orthopedics, Inc. · Orthopedic

Aug 2025

Decision

273d

Days

Class 2

Risk

About This 510(k) Submission

K243634 is an FDA 510(k) clearance for the Maxx Libertas Bipolar Hip Head (Bipolar Hip), a Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (Class II — Special Controls, product code KWY), submitted by Maxx Orthopedics, Inc. (Norristown, US). The FDA issued a Cleared decision on August 25, 2025, 273 days after receiving the submission on November 25, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3390.

Submission Details

510(k) Number	K243634 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 25, 2024
Decision Date	August 25, 2025
Days to Decision	273 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3390