Cleared Traditional

Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)

K253171 · Maxx Orthopedics, Inc. · Orthopedic

Jan 2026

Decision

111d

Days

Class 2

Risk

About This 510(k) Submission

K253171 is an FDA 510(k) clearance for the Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS 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 January 15, 2026, 111 days after receiving the submission on September 26, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K253171 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 2025
Decision Date	January 15, 2026
Days to Decision	111 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