Polycentric Total Knee Metal Tibial

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K792240 ↗

FDA Product Code

HSX

Device Class

Class II

Regulation

21 CFR Part 888.3520

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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See all devices from Howmedica Corp. →

• What is the Polycentric Total Knee Metal Tibial implant used for?

  The Polycentric Total Knee Metal Tibial is a Class 2 orthopedic prosthesis designed for total knee replacement procedures. It features a polycentric mechanism that improves knee kinematics and is intended for cemented implantation in total knee arthroplasty surgeries.

• How is the Polycentric Total Knee Metal Tibial supplied?

  The device is supplied as a metal tibial component specifically designed for use in total knee arthroplasty procedures. It is manufactured by Howmedica Corp. and is part of the orthopedic specialty devices category.

• What is the regulatory status of the Polycentric Total Knee Metal Tibial?

  The device received FDA 510(k) clearance on December 5, 1979, with the K792240 number and is classified under product code HSX. It was determined to be substantially equivalent to predicate devices through the traditional clearance pathway.

• Is the Polycentric Total Knee Metal Tibial reusable or single-use?

  The device information does not specify whether the Polycentric Total Knee Metal Tibial is designed for single-use or multiple uses. As a surgical implant, its reuse would depend on clinical guidelines and sterilization protocols established by healthcare facilities.