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

FDA 510(k)

Class II (US FDA 510(k))

510(k) K253171

by Maxx Orthopedics, Inc.

Identifiers

510(k) Number
K253171 FDA 510(k)
FDA Product Code
LZO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3353 FDA 510(k)
Regulation Number
888.3353 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) is a prosthesis for hip arthroplasty, specifically a semi-constrained hip prosthesis made of metal, ceramic, or polymer, designed for uncemented fixation. It is a line extension of the Libertas Hip System and provides uncemented femoral stem components for total hip arthroplasty, featuring a larger proximal cross-section for improved proximal filling and available in collared and non-collared options.

The device is supplied as a non-sterile, reusable implant intended for use in orthopedic surgical settings. It received FDA 510(k) clearance (K253171) under product code LZO, with a traditional clearance type and decision of substantially equivalent (SESE) on January 15, 2026, following submission on September 26, 2025. The device is classified as FDA Class II under regulation 888.3353 and is indicated for use in total hip arthroplasty procedures.

Frequently asked questions

What is the Libertas TS Stem used for?

The Libertas Taper Short (TS) Uncemented Femoral Stem is a prosthesis designed for hip arthroplasty, specifically for total hip arthroplasty procedures, providing uncemented femoral stem fixation as part of the Libertas Hip System.

Is the Libertas TS Stem sterile or non-sterile, and is it intended for single use or reuse?

The device is supplied as a non-sterile, reusable implant, meaning it must be sterilized by the healthcare provider before each surgical use and can be reprocessed and reused multiple times following validated cleaning and sterilization protocols.

What regulatory pathway was used for the Libertas TS Stem, and what is its FDA classification?

The Libertas TS Stem received FDA 510(k) clearance under submission K253171 on January 15, 2026, with a traditional clearance type and a substantially equivalent (SESE) decision, and is classified as FDA Class II under regulation 888.3353.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Libertas Taper Short (TS) Uncemented Femoral Stem… - FDA.report, Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem ..., Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Maxx Orthopedics, Inc.

Sources (1)

  • FDA 510(k) K253171 24 fields · synced Oct 6, 2026