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X-Series Integral RPP Femoral Components

FDA 510(k)

Class II (US FDA 510(k))

510(k) K042029

by Biomet, Inc.

Identifiers

510(k) Number
K042029 FDA 510(k)
FDA Product Code
LPH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3358 FDA 510(k)
Regulation Number
888.3358 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The X-Series Integral RPP Femoral Components are orthopedic hip replacement prostheses designed for use in total joint arthroplasty. This femoral component features a reduced proximal profile geometry and is manufactured from titanium alloy (Ti-6Al-4V). It is intended to be implanted by orthopedic surgeons in clinical or hospital settings as part of a hip reconstruction procedure.

The device is supplied by Biomet, Inc., a medical device manufacturer based in Warsaw, Indiana. It is regulated as a Class II orthopedic device under product code LPH and was cleared through the FDA Special 510(k) pathway under k-number K042029. The device is single-use and must be stored in accordance with manufacturer instructions; sterility is maintained through its original packaging.

Frequently asked questions

What is the X-Series Integral RPP Femoral Component used for?

It is an orthopedic hip replacement prosthesis used in total joint arthroplasty. Designed for implantation by orthopedic surgeons during hip reconstruction procedures in clinical or hospital settings.

How is the device supplied and packaged?

The device is supplied by Biomet, Inc., based in Warsaw, Indiana. It is provided in original packaging that maintains sterility. The component is single-use and must be stored according to the manufacturer's instructions.

What materials are used in its construction?

The femoral component is manufactured from titanium alloy (Ti-6Al-4V), chosen for its biocompatibility and mechanical properties suitable for orthopedic implantation.

Is this device reusable or single-use?

The X-Series Integral RPP Femoral Component is strictly single-use. Reuse or reprocessing is not permitted due to design, material integrity, and sterility assurance requirements.

What regulatory pathway was used for clearance?

The device was cleared through the FDA Special 510(k) pathway under k-number K042029. It is classified as a Class II orthopedic device under product code LPH and was determined to be substantially equivalent to existing devices.

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: X-SERIES INTEGRAL RPP FEMORAL COMPONENTS (K042029) — FDA 510 (k ..., K042029 FDA 510(k) - X-SERIES INTEGRAL RPP FEMORAL COMPONENTS, PDF 92004 EzI rx&` Ko+!ZL, PDF K042029 - X-series Integral Rpp Femoral Components

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biomet, Inc.

Sources (1)

  • FDA 510(k) K042029 24 fields · synced Oct 1, 2026