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EMPOWR Porous Knee System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K171991

by Encore Medical L.P.

Identifiers

510(k) Number
K171991 FDA 510(k)
FDA Product Code
MBH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3565 FDA 510(k)
Regulation Number
888.3565 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The EMPOWR Porous Knee System is a prosthesis for the knee, specifically a patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer device. It is classified under regulation 888.3565 and product code MBH within the orthopedic medical specialty.

The device received FDA 510(k) clearance K171991 on October 4, 2017, following a traditional review process and was found substantially equivalent. It is manufactured by Encore Medical L.P. and is intended for use in orthopedic knee replacement procedures.

Frequently asked questions

What is the EMPOWR Porous Knee System used for?

The EMPOWR Porous Knee System is a prosthesis intended for use in orthopedic knee replacement procedures, specifically designed as a patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer device to restore joint function in patients requiring knee arthroplasty.

How was the EMPOWR Porous Knee System cleared for market?

The device received FDA 510(k) clearance under number K171991 on October 4, 2017, following a traditional review process and was determined to be substantially equivalent to a legally marketed predicate device, allowing it to be marketed for its intended use in knee replacement surgery.

Who manufactures the EMPOWR Porous Knee System and where is it made?

The EMPOWR Porous Knee System is manufactured by Encore Medical L.P., located at 9800 Metric Blvd., Austin, TX 78758, United States, as indicated in the device’s authorization and establishment registration 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: EMPOWR Porous Knee System (K171991) - FDA 510 (k), EMPOWR Porous Knee System 510 (k) K171991 - FDA.report, EMPOWR Porous Knee System (K171991) — FDA 510(k) | Innolitics, EMPOWR Porous Knee System — FDA 510 (k) K171991 | MedTracker

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) K171991 24 fields · synced Sep 25, 2026