Cleared Traditional

K253171 - Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K253171 · Maxx Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2026
Decision
111d
Days
Class 2
Risk

K253171 is an FDA 510(k) clearance for the Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS 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 January 15, 2026 after a review of 111 days - within the typical 510(k) review window.

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 K253171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 122d · This submission: 111d
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 528
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K253171.
Avenir® Müller Stem
K260182 · Zimmer, Inc. · Apr 2026
implaFit® short stems
K252401 · Implantcast GmbH · Mar 2026
Coated hip implants
K250450 · Medacta International S.A. · Sep 2025
Longboard Revision Hip Stem
K243021 · Signature Orthopaedics Pty, Ltd. · Aug 2025
Z1 Hip System
K251906 · Zimmer, Inc. · Jul 2025
RECLAIM Monobloc Revision Femoral Stem
K251292 · Depuy Ireland UC · May 2025