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EXPRT Revision Hip System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K161610

by Encore Medical L.P.

Identifiers

510(k) Number
K161610 FDA 510(k)
FDA Product Code
KWZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3310 FDA 510(k)
Regulation Number
888.3310 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The EXPRT Revision Hip System is a device indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. It is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants.

The device is distributed by Encore Medical, L.P. and has received FDA 510(k) clearance under K161610. It is supplied as a non-sterile, reusable system for use in orthopedic surgical settings. Storage and handling should follow manufacturer guidelines, and MRI safety information is not specified in the provided data.

Frequently asked questions

What is the EXPRT Revision Hip System used for?

The EXPRT Revision Hip System is indicated for patients with poor bone stock or inadequate femoral head, neck, or proximal femur due to deficiencies, and is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants.

Is the EXPRT Revision Hip System sterile or non-sterile, and is it single-use or reusable?

The device is supplied as a non-sterile, reusable system, meaning it must be sterilized by the healthcare facility before each use and can be reprocessed for multiple surgical procedures following manufacturer guidelines.

Who manufactures and distributes the EXPRT Revision Hip System?

The EXPRT Revision Hip System is manufactured and distributed by Encore Medical L.P., located in Austin, Texas, as indicated in the device authorization and distribution details.

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: Exprt Revision Hip System 510 (k) FDA Premarket Notification K161610 ..., MAUDE Adverse Event Report: Encore Medical L.P. DJO SURGICAL; EXPRT ..., EXPRT Revision Hip System (K161610) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Encore Medical L.P.

Sources (1)

  • FDA 510(k) K161610 24 fields · synced Sep 24, 2026